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Trial record 2 of 233 for:    acne AND Percent

DUAC® Early Onset Efficacy Study in Japanese Subjects

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ClinicalTrials.gov Identifier: NCT02557399
Recruitment Status : Completed
First Posted : September 23, 2015
Results First Posted : February 15, 2018
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: Duac® fixed dose combination gel
Drug: ADA 0.1% gel
Drug: CLDM 1% gel
Enrollment 350
Recruitment Details DUAC® (clindamycin phosphate 1.2 percent [%] + benzoyl peroxide 3%) is the registered product of GlaxoSmithKline. This study was conducted between 07 October 2015 and 17 February 2016 in which 349 participants were randomized.
Pre-assignment Details  
Arm/Group Title DUAC ADA 0.1% +CLDM 1%
Hide Arm/Group Description Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 finger tip unit (FTU) about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks. Participants were instructed to use combination therapy of Adapalene (ADA) 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and clindamycin (CLDM) 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to inflammatory lesions (ILs) only.
Period Title: Overall Study
Started 172 177
Completed 165 169
Not Completed 7 8
Reason Not Completed
Adverse Event             6             5
Protocol Violation             0             1
Protocol-defined stopping criteria             0             1
Withdrawal by Subject             1             1
Arm/Group Title DUAC ADA 0.1% +CLDM 1% Total
Hide Arm/Group Description Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity equal to about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks. Participants were instructed to use combination therapy of ADA 0.1% gel with quantity equal to about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only. Total of all reporting groups
Overall Number of Baseline Participants 172 177 349
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 172 participants 177 participants 349 participants
20.3  (5.91) 19.8  (4.90) 20.0  (5.42)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 172 participants 177 participants 349 participants
Female
97
  56.4%
110
  62.1%
207
  59.3%
Male
75
  43.6%
67
  37.9%
142
  40.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 172 participants 177 participants 349 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
172
 100.0%
177
 100.0%
349
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percent Change in Total Lesion Counts (TLs) From Baseline to Week 2
Hide Description The assessor performed a count of IL (papules, pustules, nodular lesions), non-ILs (open and closed comedones) and total lesions (the sum of IL and non-IL) at each study visit. Lesion counts were confined to the face. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Data for adjusted mean has been reported. Percent change from Baseline is the change from Baseline divided by Baseline value multiplied by 100. The Baseline value was the latest pre-dose assessment value. The non-inflammatory lesions were counted by diagnosis based on palpation of the investigator (or sub-investigator).
Time Frame Baseline (Day 1) and Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population comprised of all randomized participants who received at least one application of study product. Only those participants with data available at the indicated time points were analyzed
Arm/Group Title DUAC ADA 0.1% +CLDM 1%
Hide Arm/Group Description:
Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
Overall Number of Participants Analyzed 169 176
Least Squares Mean (Standard Error)
Unit of Measure: Percent change in lesions
-42.16  (1.890) -35.33  (1.850)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments The analysis method was mixed model repeated measures analysis with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percent
Estimated Value -6.83
Confidence Interval (2-Sided) 95%
-11.88 to -1.78
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.
2.Secondary Outcome
Title Percent Change From Baseline in TLs to Weeks 1, 4, 8 and 12
Hide Description The assessor performed a count of IL (papules, pustules, nodular lesions), non-ILs (open and closed comedones) and total lesions (the sum of IL and non-IL) at each study visit. Lesion counts were confined to the face. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Data for adjusted mean has been reported. Percent change from Baseline is the change from Baseline divided by Baseline value multiplied by 100. The Baseline value was the latest pre-dose assessment value. The non-ILs were counted by diagnosis based on palpation of the investigator (or sub-investigator). A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.
Time Frame Baseline (Day 1) and Week 1, 4, 8, 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title DUAC ADA 0.1% +CLDM 1%
Hide Arm/Group Description:
Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
Overall Number of Participants Analyzed 172 177
Least Squares Mean (Standard Error)
Unit of Measure: Percent change in lesions
Week 1 Number Analyzed 172 participants 176 participants
-24.58  (1.729) -24.33  (1.697)
Week 4 Number Analyzed 169 participants 174 participants
-55.51  (1.670) -49.65  (1.637)
Week 8 Number Analyzed 167 participants 172 participants
-65.23  (1.544) -62.88  (1.514)
Week 12 Number Analyzed 164 participants 169 participants
-74.60  (1.314) -71.36  (1.288)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.916
Comments The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percent
Estimated Value -0.25
Confidence Interval (2-Sided) 95%
-4.85 to 4.35
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percent
Estimated Value -5.85
Confidence Interval (2-Sided) 95%
-10.29 to -1.42
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.257
Comments The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percent
Estimated Value -2.35
Confidence Interval (2-Sided) 95%
-6.42 to 1.72
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.062
Comments The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percent
Estimated Value -3.24
Confidence Interval (2-Sided) 95%
-6.64 to 0.16
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12
3.Secondary Outcome
Title Percent Change Form Baseline in Lesion Counts (ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12
Hide Description The assessor performed a count of IL (papules, pustules, nodular lesions), non-ILs (open and closed comedones). Lesion counts were confined to the face. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Data for adjusted mean has been reported. Percent change from Baseline is the change from Baseline divided by Baseline value multiplied by 100. The Baseline value was the latest pre-dose assessment value. The non-ILs were counted by diagnosis based on palpation of the investigator (or sub-investigator).
Time Frame Baseline (Day 1) and Week 1, 2, 4, 8, 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title DUAC ADA 0.1% +CLDM 1%
Hide Arm/Group Description:
Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
Overall Number of Participants Analyzed 172 177
Least Squares Mean (Standard Error)
Unit of Measure: Percent change in lesions
Week 1 ILs Number Analyzed 172 participants 176 participants
-42.97  (2.349) -37.89  (2.309)
Week 2 ILs Number Analyzed 169 participants 176 participants
-60.92  (2.209) -52.49  (2.162)
Week 4 ILs Number Analyzed 169 participants 174 participants
-70.68  (1.898) -61.30  (1.860)
Week 8 ILs Number Analyzed 167 participants 172 participants
-76.33  (1.717) -69.64  (1.682)
Week 12 ILs Number Analyzed 164 participants 169 participants
-82.07  (1.403) -77.58  (1.374)
Week 1 non-ILs Number Analyzed 172 participants 176 participants
-15.13  (2.279) -17.85  (2.239)
Week 2 non-ILs Number Analyzed 169 participants 176 participants
-32.71  (2.419) -27.01  (2.367)
Week 4 non-ILs Number Analyzed 169 participants 174 participants
-47.64  (2.171) -43.74  (2.129)
Week 8 non-ILs Number Analyzed 167 participants 172 participants
-59.50  (1.910) -58.91  (1.872)
Week 12 non-ILs Number Analyzed 164 participants 169 participants
-71.07  (1.603) -67.29  (1.571)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.115
Comments The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percent
Estimated Value -5.08
Confidence Interval (2-Sided) 95%
-11.41 to 1.25
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percent
Estimated Value -8.43
Confidence Interval (2-Sided) 95%
-14.35 to -2.51
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percent
Estimated Value -9.37
Confidence Interval (2-Sided) 95%
-14.42 to -4.33
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percent
Estimated Value -6.69
Confidence Interval (2-Sided) 95%
-11.21 to -2.16
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.50
Confidence Interval (2-Sided) 95%
-8.10 to -0.89
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for ILs
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.382
Comments The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percent
Estimated Value 2.71
Confidence Interval (2-Sided) 95%
-3.38 to 8.80
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.085
Comments The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percent
Estimated Value -5.69
Confidence Interval (2-Sided) 95%
-12.17 to 0.78
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.186
Comments The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percent
Estimated Value -3.89
Confidence Interval (2-Sided) 95%
-9.67 to 1.88
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.818
Comments The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percent
Estimated Value -0.59
Confidence Interval (2-Sided) 95%
-5.61 to 4.44
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.073
Comments The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percent
Estimated Value -3.78
Confidence Interval (2-Sided) 95%
-7.92 to 0.35
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.
4.Secondary Outcome
Title Absolute Change From Baseline in Lesion Counts (TLs, ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12
Hide Description The assessor performed a count of IL (papules, pustules, nodular lesions), non-ILs (open and closed comedones) and total lesions (the sum of IL and non-IL) at each study visit. Lesion counts were confined to the face. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Data for adjusted mean has been reported. The non-ILs were counted by diagnosis based on palpation of the investigator (or sub-investigator). A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM. The Baseline value was the latest pre-dose assessment value.
Time Frame Baseline (Day 1) and Week 1, 2, 4, 8, 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title DUAC ADA 0.1% +CLDM 1%
Hide Arm/Group Description:
Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
Overall Number of Participants Analyzed 172 177
Least Squares Mean (Standard Error)
Unit of Measure: lesion count
Week 1 TLs Number Analyzed 172 participants 176 participants
-24.4  (1.70) -24.3  (1.67)
Week 2 TLs Number Analyzed 169 participants 176 participants
-41.8  (1.88) -35.6  (1.84)
Week 4 TLs Number Analyzed 169 participants 174 participants
-56.3  (1.71) -51.6  (1.67)
Week 8 TLs Number Analyzed 167 participants 172 participants
-66.4  (1.60) -65.7  (1.57)
Week 12 TLs Number Analyzed 164 participants 169 participants
-76.2  (1.37) -74.5  (1.34)
Week 1 ILs Number Analyzed 172 participants 176 participants
-13.3  (0.74) -11.5  (0.72)
Week 2 ILs Number Analyzed 169 participants 176 participants
-19.3  (0.70) -16.3  (0.68)
Week 4 ILs Number Analyzed 169 participants 174 participants
-22.4  (0.62) -19.8  (0.60)
Week 8 ILs Number Analyzed 167 participants 172 participants
-24.3  (0.56) -22.4  (0.55)
Week 12 ILs Number Analyzed 164 participants 169 participants
-26.0  (0.48) -24.9  (0.47)
Week 1 non-ILs Number Analyzed 172 participants 176 participants
-11.1  (1.46) -12.9  (1.43)
Week 2 non-ILs Number Analyzed 169 participants 176 participants
-22.5  (1.59) -19.3  (1.56)
Week 4 non-ILs Number Analyzed 169 participants 174 participants
-34.0  (1.46) -32.0  (1.44)
Week 8 non-ILs Number Analyzed 167 participants 172 participants
-42.2  (1.33) -43.4  (1.31)
Week 12 non-ILs Number Analyzed 164 participants 169 participants
-50.2  (1.11) -49.6  (1.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.961
Comments The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-4.6 to 4.4
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for TLs. negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -6.2
Confidence Interval (2-Sided) 95%
-11.2 to -1.2
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for TLs. negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.044
Comments The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.7
Confidence Interval (2-Sided) 95%
-9.2 to -0.1
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for TLs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.747
Comments The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-4.9 to 3.5
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for TLs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.338
Comments The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.7
Confidence Interval (2-Sided) 95%
-5.3 to 1.8
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for TLs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.068
Comments The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.8
Confidence Interval (2-Sided) 95%
-3.8 to 0.1
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.0
Confidence Interval (2-Sided) 95%
-4.8 to -1.1
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.6
Confidence Interval (2-Sided) 95%
-4.3 to -1.0
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.9
Confidence Interval (2-Sided) 95%
-3.4 to -0.4
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.078
Comments The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-2.4 to 0.1
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.367
Comments The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.8
Confidence Interval (2-Sided) 95%
-2.1 to 5.7
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.148
Comments The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.1
Confidence Interval (2-Sided) 95%
-7.4 to 1.1
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.314
Comments The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.0
Confidence Interval (2-Sided) 95%
-5.9 to 1.9
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.494
Comments The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
-2.3 to 4.7
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.684
Comments The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-3.5 to 2.3
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.
5.Secondary Outcome
Title Percentage of Participants With a Minimum of 2-grade Improvement in Investigator's Static Global Assessment (ISGA) Score From Baseline to Weeks 1, 2, 4, 8 and 12
Hide Description Responder was defined as participants with a minimum 2-grade improvement in ISGA score from Baseline. ISGA scale was scored from 0-5 (0= Clear skin with no inflammatory or non-ILs, 1= Almost clear: rare non-ILs present, with no more than rare papules, 2= Mild severity: greater than Grade 1, some non-ILs with no more than few inflammatory lesions, 3= Moderate severity: greater than Grade 2, many non-ILS, may have some ILs, but no more than 1 small nodular lesion, 4= Severe: greater than Grade 3, up to many non-ILs and ILs, but no more than a few nodular lesions, 5= Very severe: many non -ILs and ILs and more than a few nodular lesions. May have cystic lesions). Percentage of participants was calculated by dividing number of participants with 2-grade improvement in ISGA score from Baseline by total number of participants value multiplied by 100.
Time Frame Week 1, 2, 4, 8, 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title DUAC ADA 0.1% +CLDM 1%
Hide Arm/Group Description:
Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
Overall Number of Participants Analyzed 172 177
Measure Type: Number
Unit of Measure: Percentage of participants
Week 1 2 0
Week 2 6 3
Week 4 12 8
Week 8 22 12
Week 12 37 27
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 2.3
Confidence Interval (2-Sided) 95%
0.1 to 4.6
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1.The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.185
Comments The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 3.0
Confidence Interval (2-Sided) 95%
-1.3 to 7.3
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.251
Comments The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 3.7
Confidence Interval (2-Sided) 95%
-2.5 to 9.9
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 10.2
Confidence Interval (2-Sided) 95%
2.4 to 18.0
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 10.7
Confidence Interval (2-Sided) 95%
0.9 to 20.4
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.
6.Secondary Outcome
Title Percentage of Participants With ISGA Score of 0 or 1 at Weeks 1, 2, 4, 8 and 12
Hide Description Responder was defined as participant with ISGA score of 0 or 1. ISGA scale was scored from 0-5 (0= Clear skin with no inflammatory or non-ILs, 1= Almost clear: rare non-ILs present, with no more than rare papules, 2= Mild severity: greater than Grade 1, some non-ILs with no more than few inflammatory lesions, 3= Moderate severity: greater than Grade 2, many non-ILS, may have some ILs, but no more than 1 small nodular lesion, 4= Severe: greater than Grade 3, up to many non-ILs and ILs, but no more than a few nodular lesions, 5= Very severe: many non -ILs and ILs and more than a few nodular lesions. May have cystic lesions). Percentage of participants was calculated by dividing number of participants with 0-1 ISGA score post Baseline by total number of participants value multiplied by 100.
Time Frame Week 1, 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title DUAC ADA 0.1% +CLDM 1%
Hide Arm/Group Description:
Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
Participants were instructed to use combination therapy of ADA) 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
Overall Number of Participants Analyzed 172 177
Measure Type: Number
Unit of Measure: Percentage of participants
Week 1 2 1
Week 2 6 5
Week 4 13 6
Week 8 20 12
Week 12 41 29
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.129
Comments The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 1.8
Confidence Interval (2-Sided) 95%
-0.7 to 4.3
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.612
Comments The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
-3.4 to 5.9
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 7.1
Confidence Interval (2-Sided) 95%
1.1 to 13.2
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.034
Comments The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 7.9
Confidence Interval (2-Sided) 95%
0.3 to 15.5
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 11.3
Confidence Interval (2-Sided) 95%
1.4 to 21.3
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.
7.Secondary Outcome
Title Percentage of Participants With at Least 50% Reduction in Lesion Counts (TLs, ILs and Non-ILs) From Baseline at Weeks 1, 2, 4, 8 and 12
Hide Description Responder was defined as participants with at least a 50% reduction in TLs, ILs and non-ILs. Data for number of participants is reported. Percentage of participants was calculated by dividing number of responders by total number of participants value multiplied by 100.
Time Frame Week 1, 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title DUAC ADA 0.1% +CLDM 1%
Hide Arm/Group Description:
Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
Overall Number of Participants Analyzed 172 177
Measure Type: Number
Unit of Measure: Percentage of participants
Week 1 TLs Number Analyzed 172 participants 176 participants
22 18
Week 2 TLs Number Analyzed 172 participants 177 participants
47 42
Week 4 TLs Number Analyzed 172 participants 177 participants
67 60
Week 8 TLs Number Analyzed 172 participants 177 participants
81 81
Week 12 TLs Number Analyzed 172 participants 177 participants
88 86
Week 1 ILs Number Analyzed 172 participants 176 participants
51 42
Week 2 ILs Number Analyzed 172 participants 177 participants
77 66
Week 4 ILs Number Analyzed 172 participants 177 participants
85 76
Week 8 ILs Number Analyzed 172 participants 177 participants
87 84
Week 12 ILs Number Analyzed 172 participants 177 participants
92 89
Week 1 non-ILs Number Analyzed 172 participants 176 participants
14 16
Week 2 non-ILs Number Analyzed 172 participants 177 participants
37 34
Week 4 non-ILs Number Analyzed 172 participants 177 participants
58 54
Week 8 non-ILs Number Analyzed 172 participants 177 participants
73 73
Week 12 non-ILs Number Analyzed 172 participants 177 participants
83 80
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.379
Comments The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 3.9
Confidence Interval (2-Sided) 95%
-4.5 to 12.3
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.409
Comments The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 4.7
Confidence Interval (2-Sided) 95%
-5.7 to 15.1
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.180
Comments The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 7.0
Confidence Interval (2-Sided) 95%
-3.1 to 17.0
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.810
Comments The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-8.8 to 7.7
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.648
Comments The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 1.9
Confidence Interval (2-Sided) 95%
-5.2 to 9.0
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.048
Comments The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 9.1
Confidence Interval (2-Sided) 95%
-1.3 to 19.6
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 11.2
Confidence Interval (2-Sided) 95%
1.8 to 20.6
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.044
Comments The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 8.6
Confidence Interval (2-Sided) 95%
0.4 to 16.9
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.345
Comments The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 3.6
Confidence Interval (2-Sided) 95%
-3.8 to 11.0
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.424
Comments The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 2.6
Confidence Interval (2-Sided) 95%
-3.5 to 8.7
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.527
Comments The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -2.0
Confidence Interval (2-Sided) 95%
-9.4 to 5.5
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.584
Comments The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 3.3
Confidence Interval (2-Sided) 95%
-6.7 to 13.4
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.519
Comments The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 3.9
Confidence Interval (2-Sided) 95%
-6.5 to 14.3
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.766
Comments The P-values are based on the Cochran-Mantel-Haenszel test stratified by center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-10.1 to 8.5
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.666
Comments The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.3
Confidence Interval (2-Sided) 95%
-5.8 to 10.5
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.
8.Secondary Outcome
Title Number of Participants With Treatment Adherence Rate at Weeks 1, 2, 4, 8 and 12
Hide Description The investigator (or sub-investigator), the product storage manager, or the blinded coordinator dispensed a study compliance log to record participant’s compliance with investigational product application from Baseline to the end of study treatment. The product storage manager or the blinded coordinator evaluated the participant’s compliance with study treatment, using the study compliance log at each visit, and recorded the compliance data in the eCRF.
Time Frame Week 1, 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title DUAC ADA 0.1% +CLDM 1%
Hide Arm/Group Description:
Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
Participants were instructed to use combination therapy of Adapalene (ADA) 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and clindamycin (CLDM) 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to inflammatory lesions (ILs) only.
Overall Number of Participants Analyzed 172 177
Measure Type: Number
Unit of Measure: Participants
week 1 143 131
week 2 125 115
week 4 110 85
week 8 89 72
week 12 88 63
9.Secondary Outcome
Title Number of Participants Who Continued Treatment at Weeks 1, 2, 4, 8 and 12
Hide Description Number of participants who continued the treatment till Week 12 was measured. Overall data for participants who have not missed any dose during the treatment period has been reported.
Time Frame Up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title DUAC ADA 0.1% +CLDM 1%
Hide Arm/Group Description:
Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
Participants were instructed to use combination therapy of Adapalene (ADA) 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and clindamycin (CLDM) 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to inflammatory lesions (ILs) only.
Overall Number of Participants Analyzed 172 177
Measure Type: Number
Unit of Measure: Participants
63 59
10.Secondary Outcome
Title Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Hide Description Participants had to rate each question on a 5-point scale of 0 to 4 (4: yes, very easy to use, 3: yes, easy, 2: slightly easy, 1: slightly difficult, 0: No) where larger score indicates more preferable participant's feeling. There were 5 questions in the questionnaire: ease of application, comfort, satisfaction with treatment (ST), comparison with prior therapies (CPT) and willingness to continue using the product (WCP).
Time Frame Week 1, 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title DUAC ADA 0.1% +CLDM 1%
Hide Arm/Group Description:
Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
Overall Number of Participants Analyzed 172 177
Measure Type: Count of Participants
Unit of Measure: Participants
Week 1: Ease of application, Score 4 Number Analyzed 172 participants 176 participants
131
  76.2%
95
  54.0%
Week 1: Ease of application, Score 3 Number Analyzed 172 participants 176 participants
38
  22.1%
66
  37.5%
Week 1: Ease of application, Score 2 Number Analyzed 172 participants 176 participants
2
   1.2%
13
   7.4%
Week 1: Ease of application, Score 1 Number Analyzed 172 participants 176 participants
1
   0.6%
2
   1.1%
Week 2: Ease of application, Score 4 Number Analyzed 169 participants 176 participants
128
  75.7%
83
  47.2%
Week 2: Ease of application, Score 3 Number Analyzed 169 participants 176 participants
38
  22.5%
75
  42.6%
Week 2: Ease of application, Score 2 Number Analyzed 169 participants 176 participants
2
   1.2%
17
   9.7%
Week 2: Ease of application, Score 1 Number Analyzed 169 participants 176 participants
1
   0.6%
1
   0.6%
Week 4: Ease of application, Score 4 Number Analyzed 169 participants 174 participants
118
  69.8%
85
  48.9%
Week 4: Ease of application, Score 3 Number Analyzed 169 participants 174 participants
49
  29.0%
70
  40.2%
Week 4: Ease of application, Score 2 Number Analyzed 169 participants 174 participants
2
   1.2%
18
  10.3%
Week 4: Ease of application, Score 1 Number Analyzed 169 participants 174 participants
0
   0.0%
1
   0.6%
Week 8: Ease of application, Score 4 Number Analyzed 167 participants 172 participants
114
  68.3%
90
  52.3%
Week 8: Ease of application, Score 3 Number Analyzed 167 participants 172 participants
50
  29.9%
60
  34.9%
Week 8: Ease of application, Score 2 Number Analyzed 167 participants 172 participants
3
   1.8%
19
  11.0%
Week 8: Ease of application, Score 1 Number Analyzed 167 participants 172 participants
0
   0.0%
3
   1.7%
Week 12: Ease of application, Score 4 Number Analyzed 164 participants 169 participants
116
  70.7%
81
  47.9%
Week 12: Ease of application, Score 3 Number Analyzed 164 participants 169 participants
44
  26.8%
68
  40.2%
Week 12: Ease of application, Score 2 Number Analyzed 164 participants 169 participants
4
   2.4%
18
  10.7%
Week 12: Ease of application, Score 1 Number Analyzed 164 participants 169 participants
0
   0.0%
2
   1.2%
Week 1: Comfort, Score 4 Number Analyzed 172 participants 176 participants
37
  21.5%
24
  13.6%
Week 1: Comfort, Score 3 Number Analyzed 172 participants 176 participants
86
  50.0%
69
  39.2%
Week 1: Comfort, Score 2 Number Analyzed 172 participants 176 participants
37
  21.5%
45
  25.6%
Week 1: Comfort, Score 1 Number Analyzed 172 participants 176 participants
7
   4.1%
32
  18.2%
Week 1: Comfort, Score 0 Number Analyzed 172 participants 176 participants
5
   2.9%
6
   3.4%
Week 2: Comfort, Score 4 Number Analyzed 169 participants 176 participants
56
  33.1%
35
  19.9%
Week 2: Comfort, Score 3 Number Analyzed 169 participants 176 participants
70
  41.4%
81
  46.0%
Week 2: Comfort, Score 2 Number Analyzed 169 participants 176 participants
36
  21.3%
42
  23.9%
Week 2: Comfort, Score 1 Number Analyzed 169 participants 176 participants
6
   3.6%
17
   9.7%
Week 2: Comfort, Score 0 Number Analyzed 169 participants 176 participants
1
   0.6%
1
   0.6%
Week 4: Comfort, Score 4 Number Analyzed 169 participants 174 participants
72
  42.6%
47
  27.0%
Week 4: Comfort, Score 3 Number Analyzed 169 participants 174 participants
75
  44.4%
80
  46.0%
Week 4: Comfort, Score 2 Number Analyzed 169 participants 174 participants
17
  10.1%
31
  17.8%
Week 4: Comfort, Score 1 Number Analyzed 169 participants 174 participants
5
   3.0%
15
   8.6%
Week 4: Comfort, Score 0 Number Analyzed 169 participants 174 participants
0
   0.0%
1
   0.6%
Week 8: Comfort, Score 4 Number Analyzed 167 participants 172 participants
79
  47.3%
53
  30.8%
Week 8: Comfort, Score 3 Number Analyzed 167 participants 172 participants
69
  41.3%
68
  39.5%
Week 8: Comfort, Score 2 Number Analyzed 167 participants 172 participants
18
  10.8%
36
  20.9%
Week 8: Comfort, Score 1 Number Analyzed 167 participants 172 participants
1
   0.6%
13
   7.6%
Week 8: Comfort, Score 0 Number Analyzed 167 participants 172 participants
0
   0.0%
2
   1.2%
Week 12: Comfort, Score 4 Number Analyzed 164 participants 169 participants
84
  51.2%
56
  33.1%
Week 12: Comfort, Score 3 Number Analyzed 164 participants 169 participants
66
  40.2%
73
  43.2%
Week 12: Comfort, Score 2 Number Analyzed 164 participants 169 participants
13
   7.9%
26
  15.4%
Week 12: Comfort, Score 1 Number Analyzed 164 participants 169 participants
1
   0.6%
13
   7.7%
Week 12: Comfort, Score 0 Number Analyzed 164 participants 169 participants
0
   0.0%
1
   0.6%
Week 1: ST, Score 4 Number Analyzed 172 participants 176 participants
36
  20.9%
21
  11.9%
Week 1: ST, Score 3 Number Analyzed 172 participants 176 participants
79
  45.9%
75
  42.6%
Week 1: ST, Score 2 Number Analyzed 172 participants 176 participants
46
  26.7%
49
  27.8%
Week 1: ST, Score 1 Number Analyzed 172 participants 176 participants
11
   6.4%
23
  13.1%
Week 1: ST, Score 0 Number Analyzed 172 participants 176 participants
0
   0.0%
8
   4.5%
Week 2: ST, Score 4 Number Analyzed 169 participants 176 participants
58
  34.3%
38
  21.6%
Week 2: ST, Score 3 Number Analyzed 169 participants 176 participants
70
  41.4%
81
  46.0%
Week 2: ST, Score 2 Number Analyzed 169 participants 176 participants
37
  21.9%
47
  26.7%
Week 2: ST, Score 1 Number Analyzed 169 participants 176 participants
4
   2.4%
7
   4.0%
Week 2: ST, Score 0 Number Analyzed 169 participants 176 participants
0
   0.0%
3
   1.7%
Week 4: ST, Score 4 Number Analyzed 169 participants 174 participants
66
  39.1%
44
  25.3%
Week 4: ST, Score 3 Number Analyzed 169 participants 174 participants
72
  42.6%
81
  46.6%
Week 4: ST, Score 2 Number Analyzed 169 participants 174 participants
27
  16.0%
40
  23.0%
Week 4: ST, Score 1 Number Analyzed 169 participants 174 participants
4
   2.4%
8
   4.6%
Week 4: ST, Score 0 Number Analyzed 169 participants 174 participants
0
   0.0%
1
   0.6%
Week 8: ST, Score 4 Number Analyzed 167 participants 172 participants
78
  46.7%
58
  33.7%
Week 8: ST, Score 3 Number Analyzed 167 participants 172 participants
67
  40.1%
72
  41.9%
Week 8: ST, Score 2 Number Analyzed 167 participants 172 participants
17
  10.2%
33
  19.2%
Week 8: ST, Score 1 Number Analyzed 167 participants 172 participants
5
   3.0%
6
   3.5%
Week 8: ST, Score 0 Number Analyzed 167 participants 172 participants
0
   0.0%
3
   1.7%
Week 12: ST, Score 4 Number Analyzed 164 participants 169 participants
82
  50.0%
63
  37.3%
Week 12: ST, Score 3 Number Analyzed 164 participants 169 participants
61
  37.2%
70
  41.4%
Week 12: ST, Score 2 Number Analyzed 164 participants 169 participants
20
  12.2%
29
  17.2%
Week 12: ST, Score 1 Number Analyzed 164 participants 169 participants
1
   0.6%
6
   3.6%
Week 12: ST, Score 0 Number Analyzed 164 participants 169 participants
0
   0.0%
1
   0.6%
Week 1: CPT, Score 4 Number Analyzed 172 participants 176 participants
77
  44.8%
53
  30.1%
Week 1: CPT, Score 3 Number Analyzed 172 participants 176 participants
50
  29.1%
45
  25.6%
Week 1: CPT, Score 2 Number Analyzed 172 participants 176 participants
38
  22.1%
61
  34.7%
Week 1: CPT, Score 1 Number Analyzed 172 participants 176 participants
7
   4.1%
11
   6.3%
Week 1: CPT, Score 0 Number Analyzed 172 participants 176 participants
0
   0.0%
6
   3.4%
Week 2: CPT, Score 4, Number Analyzed 169 participants 176 participants
90
  53.3%
57
  32.4%
Week 2: CPT, Score 3 Number Analyzed 169 participants 176 participants
51
  30.2%
55
  31.3%
Week 2: CPT, Score 2 Number Analyzed 169 participants 176 participants
25
  14.8%
54
  30.7%
Week 2: CPT, Score 1 Number Analyzed 169 participants 176 participants
2
   1.2%
10
   5.7%
Week 2: CPT, Score 0 Number Analyzed 169 participants 176 participants
1
   0.6%
0
   0.0%
Week 4: CPT, Score 4 Number Analyzed 169 participants 174 participants
100
  59.2%
67
  38.5%
Week 4: CPT, Score 3 Number Analyzed 169 participants 174 participants
47
  27.8%
52
  29.9%
Week 4: CPT, Score 2 Number Analyzed 169 participants 174 participants
18
  10.7%
46
  26.4%
Week 4: CPT, Score 1 Number Analyzed 169 participants 174 participants
4
   2.4%
8
   4.6%
Week 4: CPT, Score 0 Number Analyzed 169 participants 174 participants
0
   0.0%
1
   0.6%
Week 8: CPT, Score 4 Number Analyzed 167 participants 172 participants
109
  65.3%
73
  42.4%
Week 8: CPT, Score 3 Number Analyzed 167 participants 172 participants
38
  22.8%
50
  29.1%
Week 8: CPT, Score 2 Number Analyzed 167 participants 172 participants
19
  11.4%
40
  23.3%
Week 8: CPT, Score 1 Number Analyzed 167 participants 172 participants
1
   0.6%
8
   4.7%
Week 8: CPT, Score 0 Number Analyzed 167 participants 172 participants
0
   0.0%
1
   0.6%
Week 12: CPT, Score 4 Number Analyzed 164 participants 169 participants
112
  68.3%
78
  46.2%
Week 12: CPT, Score 3 Number Analyzed 164 participants 169 participants
42
  25.6%
47
  27.8%
Week 12: CPT, Score 2 Number Analyzed 164 participants 169 participants
8
   4.9%
35
  20.7%
Week 12: CPT, Score 1 Number Analyzed 164 participants 169 participants
2
   1.2%
7
   4.1%
Week 12: CPT, Score 0 Number Analyzed 164 participants 169 participants
0
   0.0%
2
   1.2%
Week 1: WCP, Score 4 Number Analyzed 172 participants 176 participants
64
  37.2%
36
  20.5%
Week 1: WCP, Score 3 Number Analyzed 172 participants 176 participants
79
  45.9%
78
  44.3%
Week 1: WCP, Score 2 Number Analyzed 172 participants 176 participants
25
  14.5%
39
  22.2%
Week 1: WCP, Score 1 Number Analyzed 172 participants 176 participants
4
   2.3%
19
  10.8%
Week 1: WCP, Score 0 Number Analyzed 172 participants 176 participants
0
   0.0%
4
   2.3%
Week 2: WCP, Score 4 Number Analyzed 169 participants 176 participants
75
  44.4%
55
  31.3%
Week 2: WCP, Score 3 Number Analyzed 169 participants 176 participants
72
  42.6%
70
  39.8%
Week 2: WCP, Score 2 Number Analyzed 169 participants 176 participants
19
  11.2%
38
  21.6%
Week 2: WCP, Score 1 Number Analyzed 169 participants 176 participants
3
   1.8%
13
   7.4%
Week 4: WCP, Score 4 Number Analyzed 169 participants 174 participants
88
  52.1%
63
  36.2%
Week 4: WCP, Score 3 Number Analyzed 169 participants 174 participants
63
  37.3%
75
  43.1%
Week 4: WCP, Score 2 Number Analyzed 169 participants 174 participants
15
   8.9%
26
  14.9%
Week 4: WCP, Score 1 Number Analyzed 169 participants 174 participants
3
   1.8%
10
   5.7%
Week 8: WCP, Score 4 Number Analyzed 167 participants 172 participants
90
  53.9%
62
  36.0%
Week 8: WCP, Score 3 Number Analyzed 167 participants 172 participants
59
  35.3%
74
  43.0%
Week 8: WCP, Score 2 Number Analyzed 167 participants 172 participants
15
   9.0%
27
  15.7%
Week 8: WCP, Score 1 Number Analyzed 167 participants 172 participants
3
   1.8%
9
   5.2%
Week 12: WCP, Score 4 Number Analyzed 164 participants 169 participants
94
  57.3%
70
  41.4%
Week 12: WCP, Score 3 Number Analyzed 164 participants 169 participants
56
  34.1%
65
  38.5%
Week 12: WCP, Score 2 Number Analyzed 164 participants 169 participants
12
   7.3%
23
  13.6%
Week 12: WCP, Score 1 Number Analyzed 164 participants 169 participants
1
   0.6%
11
   6.5%
Week 12: WCP, Score 0 Number Analyzed 164 participants 169 participants
1
   0.6%
0
   0.0%
11.Secondary Outcome
Title Change From Baseline in Quality of Life (QoL) Score at Week 2, 4, 8 and 12
Hide Description QOL questionnaire was assessed using Skindex-16 with 16 questions in 3 multi-item scales: symptoms, emotions and functioning for the past week: skin condition-itching, burning or stinging, hurting, being irritated, persistence/reoccurrence of skin condition, worry about condition, appearance of skin, frustration about skin, embarrassment about skin, being annoyed about your skin, feeling depressed about skin, effects of your skin on your interactions with others, effects of your skin condition on your desire to be with people, skin condition making it hard to show affection, effects of your skin condition on your daily activities and skin condition making it hard to work or do what you enjoy. Data for adjusted mean has been reported. The Baseline value was the latest pre-dose assessment value. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Scores range from 0-never bothered to 100-always bothered.
Time Frame Baseline(Day 1) and Week 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title DUAC ADA 0.1% +CLDM 1%
Hide Arm/Group Description:
Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
Overall Number of Participants Analyzed 172 177
Least Squares Mean (Standard Error)
Unit of Measure: Score on scale
Week 2 Number Analyzed 169 participants 176 participants
-0.71  (0.070) -0.49  (0.068)
Week 4 Number Analyzed 169 participants 174 participants
-1.02  (0.069) -0.80  (0.068)
Week 8 Number Analyzed 167 participants 172 participants
-1.14  (0.073) -0.92  (0.071)
Week 12 Number Analyzed 164 participants 169 participants
-1.27  (0.073) -1.10  (0.072)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.22
Confidence Interval (2-Sided) 95%
-0.40 to -0.04
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.22
Confidence Interval (2-Sided) 95%
-0.40 to -0.04
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.024
Comments [Not Specified]
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.22
Confidence Interval (2-Sided) 95%
-0.41 to -0.03
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection DUAC, ADA 0.1% +CLDM 1%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.080
Comments [Not Specified]
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.17
Confidence Interval (2-Sided) 95%
-0.36 to 0.02
Estimation Comments Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.
12.Secondary Outcome
Title Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate. For liver injury and impaired liver function, alanine aminotransferase greater than or equal to (>=)3 times upper limit of normal (ULN) and total bilirubin >=2xULN (less than [>] 35% direct) was defined.
Time Frame Up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title DUAC ADA 0.1% +CLDM 1%
Hide Arm/Group Description:
Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
Participants were instructed to use combination therapy of Adapalene (ADA) 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and clindamycin (CLDM) 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to inflammatory lesions (ILs) only.
Overall Number of Participants Analyzed 172 177
Measure Type: Count of Participants
Unit of Measure: Participants
Any AE
53
  30.8%
100
  56.5%
Any SAE
1
   0.6%
0
   0.0%
13.Secondary Outcome
Title Local Tolerability Score for Erythema, Dryness, Peeling, Itching, and Burning or Stinging
Hide Description Local tolerability score for erythema (no redness, faint red or pink coloration, barely perceptible, light red or pink coloration, medium red coloration, beet red coloration), dryness (none, barely perceptible dryness with no flakes or fissure formation, easily perceptible dryness with no flakes or fissure formation, easily noted dryness and flakes but no fissure formation, easily noted dryness with flakes and fissure formation), peeling (no peeling, mild localized peeling, mild and diffuse peeling, moderate and diffuse peeling, moderate to prominent, dense peeling) and itching and burning/stinging (normal-no discomfort, noticeable discomfort that causes intermittent awareness, continuous awareness, intermittent awareness and interferes occasionally with normal daily activities, a definite continuous discomfort that interferes with normal daily activities) was assessed on a scale of 0 to 4 (0= absent, 1= slight, 2= mild, 3= moderate and 4= severe).
Time Frame Week 1, 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title DUAC ADA 0.1% +CLDM 1%
Hide Arm/Group Description:
Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
Overall Number of Participants Analyzed 172 177
Mean (Standard Deviation)
Unit of Measure: Score on scale
Erythema Week 1 Number Analyzed 170 participants 175 participants
0.0  (0.61) 0.3  (0.72)
Erythema Week 2 Number Analyzed 169 participants 175 participants
0.0  (0.68) 0.0  (0.70)
Erythema Week 4 Number Analyzed 169 participants 174 participants
-0.1  (0.57) -0.1  (0.64)
Erythema Week 8 Number Analyzed 165 participants 171 participants
-0.2  (0.68) -0.2  (0.69)
Erythema Week 12 Number Analyzed 165 participants 168 participants
-0.2  (0.78) -0.3  (0.67)
Dryness Week 1 Number Analyzed 170 participants 175 participants
0.1  (0.54) 0.6  (0.95)
Dryness Week 2 Number Analyzed 169 participants 175 participants
0.0  (0.50) 0.1  (0.58)
Dryness Week 4 Number Analyzed 169 participants 174 participants
0.0  (0.52) 0.1  (0.49)
Dryness Week 8 Number Analyzed 165 participants 171 participants
0.0  (0.58) 0.1  (0.46)
Dryness Week 12 Number Analyzed 165 participants 168 participants
0.0  (0.45) 0.0  (0.35)
Peeling Week 1 Number Analyzed 170 participants 175 participants
0.1  (0.43) 0.5  (0.88)
Peeling Week 2 Number Analyzed 169 participants 175 participants
0.1  (0.33) 0.2  (0.55)
Peeling Week 4 Number Analyzed 169 participants 174 participants
0.0  (0.34) 0.1  (0.42)
Peeling Week 8 Number Analyzed 165 participants 171 participants
0.1  (0.39) 0.1  (0.46)
Peeling Week 12 Number Analyzed 165 participants 168 participants
0.0  (0.31) 0.0  (0.32)
Itching Week 1 Number Analyzed 170 participants 175 participants
0.0  (0.64) 0.1  (0.81)
Itching Week 2 Number Analyzed 169 participants 175 participants
0.0  (0.60) 0.1  (0.77)
Itching Week 4 Number Analyzed 169 participants 174 participants
-0.1  (0.68) -0.1  (0.62)
Itching Week 8 Number Analyzed 165 participants 171 participants
-0.2  (0.63) -0.1  (0.58)
Itching Week 12 Number Analyzed 165 participants 168 participants
-0.2  (0.66) -0.2  (0.56)
Burning/Stinging Week 1 Number Analyzed 170 participants 175 participants
0.0  (0.48) 0.5  (0.85)
Burning/Stinging Week 2 Number Analyzed 169 participants 175 participants
0.0  (0.44) 0.2  (0.66)
Burning/Stinging Week 4 Number Analyzed 169 participants 174 participants
0.0  (0.44) 0.0  (0.47)
Burning/Stinging Week 8 Number Analyzed 165 participants 171 participants
0.0  (0.34) 0.1  (0.53)
Burning/Stinging Week 12 Number Analyzed 165 participants 168 participants
0.0  (0.39) 0.0  (0.40)
14.Secondary Outcome
Title Number of Participants With Severity of AEs
Hide Description The severity of AEs was assessed by the investigator; events were assigned to one of the following categories: mild, an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; moderate, an event that was sufficiently discomforting to interfere with normal everyday activities; and severe, an event that prevented normal everyday activities.
Time Frame Up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title DUAC ADA 0.1% +CLDM 1%
Hide Arm/Group Description:
Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
Overall Number of Participants Analyzed 172 177
Measure Type: Count of Participants
Unit of Measure: Participants
Mild
46
  26.7%
91
  51.4%
Modertae
6
   3.5%
7
   4.0%
Severe
1
   0.6%
2
   1.1%
Time Frame AE and SAE were collected up to Week 12.
Adverse Event Reporting Description For AE and SAE, ITT population was analyzed.
 
Arm/Group Title Duac ADA 0.1% +CLDM 1%
Hide Arm/Group Description Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks. Participants were instructed to use combination therapy of Adapalene (ADA) 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and clindamycin (CLDM) 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to inflammatory lesions (ILs) only.
All-Cause Mortality
Duac ADA 0.1% +CLDM 1%
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Duac ADA 0.1% +CLDM 1%
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/172 (0.58%)      0/177 (0.00%)    
Gastrointestinal disorders     
Duodenal ulcer  1  1/172 (0.58%)  0/177 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Duac ADA 0.1% +CLDM 1%
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   34/172 (19.77%)      78/177 (44.07%)    
General disorders     
Application site dryness  1  16/172 (9.30%)  16 44/177 (24.86%)  46
Application site pain  1  3/172 (1.74%)  3 20/177 (11.30%)  21
Application site erythema  1  4/172 (2.33%)  4 11/177 (6.21%)  12
Infections and infestations     
Nasopharyngitis  1  12/172 (6.98%)  13 15/177 (8.47%)  16
Skin and subcutaneous tissue disorders     
Eczema  1  2/172 (1.16%)  2 10/177 (5.65%)  11
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02557399     History of Changes
Other Study ID Numbers: 201884
First Submitted: June 11, 2015
First Posted: September 23, 2015
Results First Submitted: February 24, 2017
Results First Posted: February 15, 2018
Last Update Posted: August 20, 2018