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A Efficacy and Safety of Duac™Compared With Clindamycin Phosphate Gel in the Treatment of Mild to Moderate Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT01915732
Recruitment Status : Completed
First Posted : August 5, 2013
Results First Posted : November 25, 2014
Last Update Posted : February 28, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: Duac™Once Daily Gel
Drug: 1% clindamycin phosphate gel
Enrollment 1018
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Duac Once Daily Gel Dalin Gel
Hide Arm/Group Description Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks. Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
Period Title: Overall Study
Started 500 516
Completed 430 445
Not Completed 70 71
Reason Not Completed
Withdrawal by Subject             18             18
Failure to Meet Randomization Criteria             1             0
Adverse Event             12             4
Protocol Violation             5             5
Lack of Efficacy             6             11
Lost to Follow-up             22             26
Par. Improved, Voluntary (Vol) exit             1             0
Par. Conscious Ineffective Vol Exit             1             0
Drug Release Error             1             0
Recovered             1             0
Pregnancy             1             0
Poor Perceived Efficacy             1             0
Par. Unable to Come to the Hospital             0             1
Got Well             0             1
Par. not Willing to Continue Treatment             0             1
Par. Refused to Hospital Visits             0             1
Job Transfer             0             1
Improper Facial Procedure             0             1
Poor Conscious Effect             0             1
Arm/Group Title Duac Once Daily Gel Dalin Gel Total
Hide Arm/Group Description Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks. Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 500 516 1016
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 500 participants 516 participants 1016 participants
23.4  (4.64) 23.3  (4.29) 23.4  (4.46)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 500 participants 516 participants 1016 participants
Female
382
  76.4%
383
  74.2%
765
  75.3%
Male
118
  23.6%
133
  25.8%
251
  24.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 500 participants 516 participants 1016 participants
Asian 500 515 1015
White 0 1 1
1.Primary Outcome
Title Absolute Change in Total Lesion Count From Baseline to Week 12
Hide Description The assessor performed a count of inflammatory lesions (IL) (papules, pustules, nodules, and cysts), non-inflammatory lesions (NIL) (open and closed comedones) and total lesions (the sum of IL and NIL) at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Parameters were estimated using analysis of covariance (ANCOVA) with treatment, center, treatment-by-centre interaction and Baseline lesion count in the model. Missing values were imputed using the last observation carried forward (LOCF), i.e., the last available observation was used to estimate subsequent missing data.
Time Frame Baseline (Week 0) and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all participants who were randomized and received at least one dose of study medication.
Arm/Group Title Duac Once Daily Gel Dalin Gel
Hide Arm/Group Description:
Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
Overall Number of Participants Analyzed 484 499
Least Squares Mean (Standard Error)
Unit of Measure: Change in lesion count
-55.7  (1.05) -51.2  (1.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duac Once Daily Gel, Dalin Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.5
Confidence Interval (2-Sided) 95%
-7.4 to -1.6
Estimation Comments [Not Specified]
2.Primary Outcome
Title Absolute Change in Total Lesion Count From Baseline to Week 12
Hide Description The assessor performed a count of inflammatory lesions (IL) (papules, pustules, nodules, and cysts), non-inflammatory lesions (NIL) (open and closed comedones) and total lesions (the sum of IL and NIL) at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Parameters were estimated using analysis of covariance (ANCOVA) with treatment, center, treatment-by-centre interaction and Baseline lesion count in the model. Missing values were imputed using the last observation carried forward (LOCF), i.e., the last available observation was used to estimate subsequent missing data.
Time Frame Baseline (Week 0) and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol (PP) Population: all participants included in the ITT Population who did not have a noteworthy protocol deviation that influenced effect.
Arm/Group Title Duac Once Daily Gel Dalin Gel
Hide Arm/Group Description:
Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
Overall Number of Participants Analyzed 433 449
Least Squares Mean (Standard Error)
Unit of Measure: Change in lesion count
-56.7  (0.97) -52.1  (0.96)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duac Once Daily Gel, Dalin Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.6
Confidence Interval (2-Sided) 95%
-7.3 to -1.9
Estimation Comments [Not Specified]
3.Primary Outcome
Title Number of Participants With an Improvement of 2 Grades in the Investigator Static Global Assessment (ISGA) Score From Baseline to Week 12
Hide Description ISGA success is defined as the improvement of 2 grades or more in the participant's acne severity scale at Week 12. Acne severity of the participants' face was assessed by the assessor using the ISGA scale, ranging from 0 to 4: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than one small IL; 2=mild, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: up to many NILs and ILs, but no more than a few NLs. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.
Time Frame Baseline (Week 0) and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Duac Once Daily Gel Dalin Gel
Hide Arm/Group Description:
Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
Overall Number of Participants Analyzed 500 516
Measure Type: Number
Unit of Measure: Participants
151 117
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duac Once Daily Gel, Dalin Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
4.Primary Outcome
Title Number of Participants With an Improvement of 2 Grades in the Investigator Static Global Assessment (ISGA) Score From Baseline to Week 12
Hide Description ISGA success is defined as the improvement of 2 grades or more in the participant's acne severity scale at Week 12. Acne severity of the participants' face was assessed by the assessor using the ISGA scale, ranging from 0 to 4: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than one small IL; 2=mild, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: up to many NILs and ILs, but no more than a few NLs. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data .
Time Frame Baseline (Week 0) and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
PP Population
Arm/Group Title Duac Once Daily Gel Dalin Gel
Hide Arm/Group Description:
Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
Overall Number of Participants Analyzed 442 461
Measure Type: Number
Unit of Measure: Participants
142 110
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duac Once Daily Gel, Dalin Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
5.Secondary Outcome
Title Absolute Change in Inflammatory Lesion Counts and Non-inflammatory Lesion Counts From Baseline to Week 12
Hide Description The assessor performed a count of ILs (papules, pustules, nodules, and cysts), NILs (open and closed comedones at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Analysis of covariance (ANCOVA) model was used with terms for Baseline lesion count, treatment, and center. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.
Time Frame Baseline (Week 0) and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Duac Once Daily Gel Dalin Gel
Hide Arm/Group Description:
Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
Overall Number of Participants Analyzed 484 499
Least Squares Mean (Standard Error)
Unit of Measure: Lesions
IL -20.6  (0.36) -19.7  (0.35)
NIL -35.0  (0.83) -31.6  (0.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duac Once Daily Gel, Dalin Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.077
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-1.8 to 0.1
Estimation Comments Statistical data for the category=IL.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Duac Once Daily Gel, Dalin Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.4
Confidence Interval (2-Sided) 95%
-5.7 to -1.1
Estimation Comments Statistical data for the category=NIL.
6.Secondary Outcome
Title Absolute Change in Inflammatory Lesion Counts and Non-inflammatory Lesion Counts From Baseline to Week 12
Hide Description The assessor performed a count of ILs (papules, pustules, nodules, and cysts), NILs (open and closed comedones at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Analysis of covariance (ANCOVA) model was used with terms for Baseline lesion count, treatment, and center. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.
Time Frame Baseline (Week 0) and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
PP Population
Arm/Group Title Duac Once Daily Gel Dalin Gel
Hide Arm/Group Description:
Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
Overall Number of Participants Analyzed 433 449
Least Squares Mean (Standard Error)
Unit of Measure: Lesions
IL -20.9  (0.34) -19.9  (0.34)
NIL -35.7  (0.78) -32.3  (0.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duac Once Daily Gel, Dalin Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.028
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-2.0 to -0.1
Estimation Comments Statistical data for the category=IL.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Duac Once Daily Gel, Dalin Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.4
Confidence Interval (2-Sided) 95%
-5.5 to -1.2
Estimation Comments Statistical data for the category=NIL.
7.Secondary Outcome
Title Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 12
Hide Description The assessor performed a count of ILs (papules, pustules, nodules, and cysts), NILs (open and closed comedones) and total lesions (the sum of ILs and NILs)at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Analysis of covariance (ANCOVA) model was used with terms for Baseline lesion count, treatment, and center. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.
Time Frame Baseline (Week 0) and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Duac Once Daily Gel Dalin Gel
Hide Arm/Group Description:
Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
Overall Number of Participants Analyzed 484 499
Least Squares Mean (Standard Error)
Unit of Measure: Percent change in lesions
IL -0.78  (0.013) -0.75  (0.013)
NIL -0.67  (0.018) -0.60  (0.018)
Total -0.72  (0.013) -0.67  (0.013)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duac Once Daily Gel, Dalin Gel
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 ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.03
Confidence Interval (2-Sided) 95%
-0.06 to 0.00
Estimation Comments Statistical data for the category=IL.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Duac Once Daily Gel, Dalin Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.07
Confidence Interval (2-Sided) 95%
-0.12 to -0.02
Estimation Comments Statistical data for the category=NIL.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duac Once Daily Gel, Dalin Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.05
Confidence Interval (2-Sided) 95%
-0.09 to -0.02
Estimation Comments Statisticial data for the category=Total.
8.Secondary Outcome
Title Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 12
Hide Description The assessor performed a count of ILs (papules, pustules, nodules, and cysts), NILs (open and closed comedones) and total lesions (the sum of ILs and NILs)at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Analysis of covariance (ANCOVA) model was used with terms for Baseline lesion count, treatment, and center. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.
Time Frame Baseline (Week 0) and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
PP Population
Arm/Group Title Duac Once Daily Gel Dalin Gel
Hide Arm/Group Description:
Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
Overall Number of Participants Analyzed 433 449
Least Squares Mean (Standard Error)
Unit of Measure: Percent change in lesions
IL -0.80  (0.012) -0.76  (0.012)
NIL -0.70  (0.018) -0.61  (0.017)
Total -0.74  (0.012) -0.68  (0.012)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duac Once Daily Gel, Dalin Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.04
Confidence Interval (2-Sided) 95%
-0.07 to -0.00
Estimation Comments Statistical data for the category=IL.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Duac Once Daily Gel, Dalin Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.09
Confidence Interval (2-Sided) 95%
-0.14 to -0.04
Estimation Comments Statistical data for the category=NIL.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duac Once Daily Gel, Dalin Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.07
Confidence Interval (2-Sided) 95%
-0.10 to -0.03
Estimation Comments Statistical data for the category=Total.
9.Secondary Outcome
Title Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12
Hide Description The assessor evaluated the acne severity of the participants' face using the ISGA scale, ranging from 0 to 4: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than one small IL; 2=mild, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: up to many NILs and ILs, but no more than a few NLs. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Duac Once Daily Gel Dalin Gel
Hide Arm/Group Description:
Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
Overall Number of Participants Analyzed 500 516
Measure Type: Number
Unit of Measure: Participants
209 151
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duac Once Daily Gel, Dalin Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
10.Secondary Outcome
Title Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12
Hide Description The assessor evaluated the acne severity of the participants' face using the ISGA scale, ranging from 0 to 4: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than one small IL; 2=mild, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: up to many NILs and ILs, but no more than a few NLs. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
PP Population
Arm/Group Title Duac Once Daily Gel Dalin Gel
Hide Arm/Group Description:
Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
Overall Number of Participants Analyzed 442 461
Measure Type: Number
Unit of Measure: Participants
196 144
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duac Once Daily Gel, Dalin Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Time Frame Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12).
Adverse Event Reporting Description SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
 
Arm/Group Title Duac Once Daily Gel Dalin Gel
Hide Arm/Group Description Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks. Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
All-Cause Mortality
Duac Once Daily Gel Dalin Gel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Duac Once Daily Gel Dalin Gel
Affected / at Risk (%) Affected / at Risk (%)
Total   1/500 (0.20%)   0/516 (0.00%) 
Injury, poisoning and procedural complications     
Thermal burn  1 [1]  1/500 (0.20%)  0/516 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
[1]
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Duac Once Daily Gel Dalin Gel
Affected / at Risk (%) Affected / at Risk (%)
Total   71/500 (14.20%)   41/516 (7.95%) 
Blood and lymphatic system disorders     
Lymph node pain  1  0/500 (0.00%)  1/516 (0.19%) 
Eye disorders     
Eyelid oedema  1  1/500 (0.20%)  0/516 (0.00%) 
Gastrointestinal disorders     
Abdominal discomfort  1  3/500 (0.60%)  0/516 (0.00%) 
Dry mouth  1  1/500 (0.20%)  0/516 (0.00%) 
Abdominal pain  1  0/500 (0.00%)  1/516 (0.19%) 
Abdominal pain upper  1  0/500 (0.00%)  1/516 (0.19%) 
Cheilitis  1  0/500 (0.00%)  1/516 (0.19%) 
Constipation  1  0/500 (0.00%)  1/516 (0.19%) 
Diarrhoea  1  0/500 (0.00%)  5/516 (0.97%) 
Gingival bleeding  1  0/500 (0.00%)  1/516 (0.19%) 
Haemorrhoids  1  0/500 (0.00%)  1/516 (0.19%) 
Nausea  1  0/500 (0.00%)  1/516 (0.19%) 
Retching  1  0/500 (0.00%)  1/516 (0.19%) 
General disorders     
Application site erythema  1  26/500 (5.20%)  4/516 (0.78%) 
Application site pruritus  1  16/500 (3.20%)  3/516 (0.58%) 
Application site swelling  1  13/500 (2.60%)  3/516 (0.58%) 
Application site erosion  1  6/500 (1.20%)  1/516 (0.19%) 
Application site pain  1  6/500 (1.20%)  2/516 (0.39%) 
Application site dryness  1  4/500 (0.80%)  0/516 (0.00%) 
Application site warmth  1  4/500 (0.80%)  0/516 (0.00%) 
Application site dermatitis  1  3/500 (0.60%)  1/516 (0.19%) 
Application site reaction  1  1/500 (0.20%)  0/516 (0.00%) 
Hyperhidrosis  1  1/500 (0.20%)  0/516 (0.00%) 
Hyperpyrexia  1  1/500 (0.20%)  0/516 (0.00%) 
Pyrexia  1  1/500 (0.20%)  2/516 (0.39%) 
Infections and infestations     
Nasopharyngitis  1  13/500 (2.60%)  13/516 (2.52%) 
Gastroenteritis  1  2/500 (0.40%)  2/516 (0.39%) 
Herpes simplex  1  2/500 (0.40%)  0/516 (0.00%) 
Bronchitis  1  1/500 (0.20%)  0/516 (0.00%) 
Nasal abscess  1  1/500 (0.20%)  0/516 (0.00%) 
Onychomycosis  1  1/500 (0.20%)  0/516 (0.00%) 
Upper respiratory tract infection  1  1/500 (0.20%)  4/516 (0.78%) 
Pharyngitis  1  0/500 (0.00%)  1/516 (0.19%) 
Rash pustular  1  0/500 (0.00%)  1/516 (0.19%) 
Rhinitis  1  0/500 (0.00%)  1/516 (0.19%) 
Injury, poisoning and procedural complications     
Injury  1  1/500 (0.20%)  0/516 (0.00%) 
Musculoskeletal and connective tissue disorders     
Pain in jaw  1  1/500 (0.20%)  0/516 (0.00%) 
Nervous system disorders     
Headache  1  2/500 (0.40%)  1/516 (0.19%) 
Dizziness  1  1/500 (0.20%)  1/516 (0.19%) 
Psychiatric disorders     
Insomnia  1  0/500 (0.00%)  1/516 (0.19%) 
Reproductive system and breast disorders     
Dysmenorrhoea  1  1/500 (0.20%)  0/516 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  2/500 (0.40%)  0/516 (0.00%) 
Oropharyngeal pain  1  2/500 (0.40%)  2/516 (0.39%) 
Rhinitis allergic  1  0/500 (0.00%)  1/516 (0.19%) 
Skin and subcutaneous tissue disorders     
Dermatitis contact  1  1/500 (0.20%)  0/516 (0.00%) 
Rash vesicular  1  1/500 (0.20%)  0/516 (0.00%) 
Urticaria  1  1/500 (0.20%)  1/516 (0.19%) 
Papule  1  0/500 (0.00%)  1/516 (0.19%) 
Surgical and medical procedures     
Eyelid operation  1  1/500 (0.20%)  0/516 (0.00%) 
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: NCT01915732     History of Changes
Other Study ID Numbers: 114543
First Submitted: April 5, 2013
First Posted: August 5, 2013
Results First Submitted: November 20, 2014
Results First Posted: November 25, 2014
Last Update Posted: February 28, 2017