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Trial record 48 of 79 for:    acne AND almost AND facial

Study STF115287, a Clinical Confirmation Study of GSK2585823 in the Treatment of Acne Vulgaris in Japanese Subjects

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ClinicalTrials.gov Identifier: NCT01445301
Recruitment Status : Completed
First Posted : October 3, 2011
Results First Posted : April 27, 2018
Last Update Posted : April 27, 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: GSK2585823(CLDM 1%-BPO 3% gel)
Drug: CLDM 1% gel twice daily
Enrollment 800
Recruitment Details A total of 800 Japanese participants across 26 investigational centers in Japan, with Acne Vulgaris were enrolled in this study. The study was conducted from 27 September 2011 - 02 August 2012.
Pre-assignment Details  
Arm/Group Title GSK2585823 Once Daily GSK2585823 Twice Daily CLDM Twice Daily
Hide Arm/Group Description Participants were instructed to apply GSK2585823 (Topical gel in 1 gram (g) containing clindamycin (CLDM) 10 milligram (mg) and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU (Finger Tip Unit). Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU. Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Period Title: Overall Study
Started 204 297 299
Completed 183 262 290
Not Completed 21 35 9
Reason Not Completed
Adverse Event             15             25             4
Lack of Efficacy             0             1             0
Protocol Violation             1             0             0
Protocol-Defined Stopping Criteria             0             1             1
Physician Decision             0             2             0
Withdrawal by Subject             5             6             4
Arm/Group Title GSK2585823 Once Daily GSK2585823 Twice Daily CLDM Twice Daily Total
Hide Arm/Group Description Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU. Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU. Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU. Total of all reporting groups
Overall Number of Baseline Participants 204 296 299 799
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population comprised all randomized participants who received at least one application of investigational product. One participant excluded was randomized but was not administered study drug. 799 participant were included in the ITT population.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 204 participants 296 participants 299 participants 799 participants
20.4  (6.06) 20.7  (6.33) 21.1  (6.55) 20.8  (6.34)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 204 participants 296 participants 299 participants 799 participants
Female
139
  68.1%
187
  63.2%
202
  67.6%
528
  66.1%
Male
65
  31.9%
109
  36.8%
97
  32.4%
271
  33.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 204 participants 296 participants 299 participants 799 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
204
 100.0%
296
 100.0%
299
 100.0%
799
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Absolute Change From Baseline to Week 12 in Total Lesion Counts.
Hide Description The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from post-randomization value at Week 12.
Time Frame Baseline (Day 1) and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Only those participants available at the indicated time points were analyzed.
Arm/Group Title GSK2585823 Once Daily GSK2585823 Twice Daily CLDM Twice Daily
Hide Arm/Group Description:
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Overall Number of Participants Analyzed 201 289 299
Least Squares Mean (Standard Error)
Unit of Measure: lesion count
-57.2  (1.94) -60.8  (1.53) -49.8  (1.52)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK2585823 Twice Daily, CLDM Twice Daily
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 (Net)
Estimated Value -11.0
Confidence Interval (2-Sided) 95%
-15.0 to -7.0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GSK2585823 Once Daily, CLDM Twice Daily
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -8.2
Confidence Interval (2-Sided) 95%
-12.9 to -3.6
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Absolute Change From Baseline to Weeks 1, 2, 4, and 8 in Total Lesion Counts
Hide Description The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from value at indicated time points.
Time Frame Baseline (Day 1) and Weeks 1, 2, 4, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Only those participants available at the specified time points were analyzed.
Arm/Group Title GSK2585823 Once Daily GSK2585823 Twice Daily CLDM Twice Daily
Hide Arm/Group Description:
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Overall Number of Participants Analyzed 204 296 299
Mean (Standard Deviation)
Unit of Measure: lesion count
WEEK 1 Number Analyzed 200 participants 287 participants 295 participants
-22.9  (19.81) -25.6  (24.91) -16.9  (24.40)
WEEK 2 Number Analyzed 201 participants 289 participants 299 participants
-32.9  (29.18) -37.9  (28.91) -26.6  (30.00)
WEEK 4 Number Analyzed 201 participants 289 participants 299 participants
-41.4  (27.41) -47.3  (31.04) -34.8  (30.92)
WEEK 8 Number Analyzed 201 participants 289 participants 299 participants
-49.1  (28.97) -54.4  (34.65) -42.7  (33.49)
3.Secondary Outcome
Title Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts
Hide Description The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from value at indicated time points.
Time Frame Baseline (Day 1) and Weeks 1, 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Only those participants available at the specified time points were analyzed.
Arm/Group Title GSK2585823 Once Daily GSK2585823 Twice Daily CLDM Twice Daily
Hide Arm/Group Description:
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Overall Number of Participants Analyzed 204 296 299
Least Squares Mean (Standard Error)
Unit of Measure: Lesion count
Inflammatory lesions,Week 1 Number Analyzed 200 participants 287 participants 295 participants
-11.5  (0.60) -11.1  (0.54) -8.5  (0.50)
Inflammatory lesions,Week 2 Number Analyzed 201 participants 289 participants 299 participants
-14.8  (0.90) -16.4  (0.61) -13.1  (0.76)
Inflammatory lesions,Week 4 Number Analyzed 201 participants 289 participants 299 participants
-18.3  (0.93) -19.1  (0.62) -16.3  (0.78)
Inflammatory lesions,Week 8 Number Analyzed 201 participants 289 participants 299 participants
-21.0  (0.98) -21.3  (0.69) -18.3  (0.82)
Inflammatory lesions,Week 12 Number Analyzed 201 participants 289 participants 299 participants
-22.9  (0.99) -23.3  (0.69) -20.3  (0.83)
Non-Inflammatory lesions,Week 1 Number Analyzed 200 participants 287 participants 295 participants
-13.1  (1.26) -15.6  (1.08) -9.7  (1.06)
Non-Inflammatory lesions,Week 2 Number Analyzed 201 participants 289 participants 299 participants
-20.3  (1.53) -22.8  (1.28) -14.9  (1.29)
Non-Inflammatory lesions,Week 4 Number Analyzed 201 participants 289 participants 299 participants
-25.2  (1.58) -28.9  (1.33) -19.4  (1.32)
Non-Inflammatory lesions,Week 8 Number Analyzed 201 participants 289 participants 299 participants
-30.4  (1.62) -33.9  (1.36) -24.9  (1.36)
Non-Inflammatory lesions,Week 12 Number Analyzed 201 participants 289 participants 299 participants
-34.3  (1.60) -37.5  (1.31) -28.7  (1.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK2585823 Once Daily, CLDM Twice Daily
Comments WEEK 1
Type of Statistical Test Non-Inferiority
Comments If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.0
Confidence Interval (2-Sided) 95%
-4.4 to -1.5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GSK2585823 Once Daily, CLDM Twice Daily
Comments WEEK 2
Type of Statistical Test Non-Inferiority
Comments If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established
Statistical Test of Hypothesis P-Value 0.113
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.8
Confidence Interval (2-Sided) 95%
-4.0 to 0.4
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GSK2585823 Once Daily, CLDM Twice Daily
Comments WEEK 4
Type of Statistical Test Non-Inferiority
Comments If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established
Statistical Test of Hypothesis P-Value 0.084
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.0
Confidence Interval (2-Sided) 95%
-4.2 to 0.3
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GSK2585823 Once Daily, CLDM Twice Daily
Comments WEEK 8
Type of Statistical Test Non-Inferiority
Comments If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established
Statistical Test of Hypothesis P-Value 0.026
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.7
Confidence Interval (2-Sided) 95%
-5.1 to -0.3
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection GSK2585823 Once Daily, CLDM Twice Daily
Comments WEEK 12
Type of Statistical Test Non-Inferiority
Comments If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established
Statistical Test of Hypothesis P-Value 0.030
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.6
Confidence Interval (2-Sided) 95%
-5.0 to -0.3
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection GSK2585823 Once Daily, CLDM Twice Daily
Comments WEEK 1
Type of Statistical Test Non-Inferiority
Comments If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established
Statistical Test of Hypothesis P-Value 0.028
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.4
Confidence Interval (2-Sided) 95%
-6.5 to -0.4
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection GSK2585823 Once Daily, CLDM Twice Daily
Comments WEEK 2
Type of Statistical Test Non-Inferiority
Comments If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -5.4
Confidence Interval (2-Sided) 95%
-9.1 to -1.7
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection GSK2585823 Once Daily, CLDM Twice Daily
Comments WEEK 4
Type of Statistical Test Non-Inferiority
Comments If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value -5.8
Confidence Interval (2-Sided) 95%
-9.6 to -1.9
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection GSK2585823 Once Daily, CLDM Twice Daily
Comments WEEK 8
Type of Statistical Test Non-Inferiority
Comments If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -5.5
Confidence Interval (2-Sided) 95%
-9.4 to -1.6
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection GSK2585823 Once Daily, CLDM Twice Daily
Comments WEEK 12
Type of Statistical Test Non-Inferiority
Comments If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -5.6
Confidence Interval (2-Sided) 95%
-9.5 to -1.7
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection GSK2585823 Twice Daily, CLDM Twice Daily
Comments WEEK 1
Type of Statistical Test Superiority
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 (Net)
Estimated Value -2.5
Confidence Interval (2-Sided) 95%
-3.9 to -1.1
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection GSK2585823 Twice Daily, CLDM Twice Daily
Comments WEEK 2
Type of Statistical Test Superiority
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 (Net)
Estimated Value -3.2
Confidence Interval (2-Sided) 95%
-4.7 to -1.6
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection GSK2585823 Twice Daily, CLDM Twice Daily
Comments WEEK 4
Type of Statistical Test Superiority
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 (Net)
Estimated Value -2.5
Confidence Interval (2-Sided) 95%
-4.1 to -0.9
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection GSK2585823 Twice Daily, CLDM Twice Daily
Comments WEEK 8
Type of Statistical Test Superiority
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 (Net)
Estimated Value -2.7
Confidence Interval (2-Sided) 95%
-4.5 to -0.9
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection GSK2585823 Twice Daily, CLDM Twice Daily
Comments WEEK 12
Type of Statistical Test Superiority
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 (Net)
Estimated Value -2.8
Confidence Interval (2-Sided) 95%
-4.6 to -1.0
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection GSK2585823 Twice Daily, CLDM Twice Daily
Comments WEEK 1
Type of Statistical Test Superiority
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 (Net)
Estimated Value -6.0
Confidence Interval (2-Sided) 95%
-8.8 to -3.2
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection GSK2585823 Twice Daily, CLDM Twice Daily
Comments WEEK 2
Type of Statistical Test Superiority
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 (Net)
Estimated Value -8.1
Confidence Interval (2-Sided) 95%
-11.4 to -4.7
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection GSK2585823 Twice Daily, CLDM Twice Daily
Comments WEEK 4
Type of Statistical Test Superiority
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 (Net)
Estimated Value -9.7
Confidence Interval (2-Sided) 95%
-13.1 to -6.2
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection GSK2585823 Twice Daily, CLDM Twice Daily
Comments WEEK 8
Type of Statistical Test Superiority
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 (Net)
Estimated Value -8.6
Confidence Interval (2-Sided) 95%
-12.1 to -5.1
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection GSK2585823 Twice Daily, CLDM Twice Daily
Comments WEEK 12
Type of Statistical Test Superiority
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 (Net)
Estimated Value -8.2
Confidence Interval (2-Sided) 95%
-11.6 to -4.8
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts
Hide Description The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from value at indicated time points.( Weeks 1, 2, 4, 8 and 12)
Time Frame Baseline (Day 1) and Weeks 1, 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Only those participants available at the specified time points were analyzed.
Arm/Group Title GSK2585823 Once Daily GSK2585823 Twice Daily CLDM Twice Daily
Hide Arm/Group Description:
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Overall Number of Participants Analyzed 204 296 299
Least Squares Mean (Standard Error)
Unit of Measure: Percent change
Total lesions,Week 1 Number Analyzed 200 participants 287 participants 295 participants
-32.42  (1.478) -33.29  (1.312) -24.71  (1.247)
Total lesions,Week 2 Number Analyzed 201 participants 289 participants 299 participants
-46.87  (1.953) -49.29  (1.544) -38.36  (1.644)
Total lesions,Week 4 Number Analyzed 201 participants 289 participants 299 participants
-57.15  (1.848) -59.98  (1.454) -48.26  (1.556)
Total lesions,Week 8 Number Analyzed 201 participants 289 participants 299 participants
-66.33  (1.935) -68.49  (1.551) -57.20  (1.630)
Total lesions,Week 12 Number Analyzed 201 participants 289 participants 299 participants
-73.85  (1.929) -75.57  (1.512) -64.42  (1.625)
Inflammatory lesions, Week 1 Number Analyzed 200 participants 287 participants 295 participants
-41.87  (1.885) -39.76  (1.704) -31.32  (1.590)
Inflammatory lesions, Week 2 Number Analyzed 201 participants 289 participants 299 participants
-55.64  (2.277) -58.31  (1.641) -48.43  (1.917)
Inflammatory lesions, Week 4 Number Analyzed 201 participants 289 participants 299 participants
-66.51  (2.181) -66.89  (1.617) -58.87  (1.837)
Inflammatory lesions, Week 8 Number Analyzed 201 participants 289 participants 299 participants
-74.86  (2.256) -74.37  (1.750) -66.13  (1.899)
Inflammatory lesions, Week 12 Number Analyzed 201 participants 289 participants 299 participants
-80.84  (2.120) -81.14  (1.598) -72.64  (1.785)
Non-Inflammatory lesions, Week 1 Number Analyzed 200 participants 287 participants 295 participants
-26.49  (1.846) -29.20  (1.697) -20.69  (1.558)
Non-Inflammatory lesions, Week 2 Number Analyzed 201 participants 289 participants 299 participants
-41.26  (2.392) -43.43  (2.022) -32.96  (2.014)
Non-Inflammatory lesions, Week 4 Number Analyzed 201 participants 289 participants 299 participants
-51.12  (2.246) -55.40  (1.847) -41.85  (1.891)
Non-Inflammatory lesions, Week 8 Number Analyzed 201 participants 289 participants 299 participants
-60.59  (2.247) -64.83  (1.844) -51.75  (1.892)
Non-Inflammatory lesions, Week 12 Number Analyzed 201 participants 289 participants 299 participants
-69.01  (2.219) -71.90  (1.804) -59.33  (1.869)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK2585823 Once Daily, CLDM Twice Daily
Comments Total Lesion Counts, WEEK 1
Type of Statistical Test Non-Inferiority or Equivalence
Comments If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -7.71
Confidence Interval (2-Sided) 95%
-11.30 to -4.12
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GSK2585823 Once Daily, CLDM Twice Daily
Comments Total Lesion Counts, WEEK 2
Type of Statistical Test Non-Inferiority or Equivalence
Comments If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -8.51
Confidence Interval (2-Sided) 95%
-13.24 to -3.77
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GSK2585823 Once Daily, CLDM Twice Daily
Comments Total Lesion Counts, WEEK 4
Type of Statistical Test Non-Inferiority or Equivalence
Comments If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -8.89
Confidence Interval (2-Sided) 95%
-13.37 to -4.41
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GSK2585823 Once Daily, CLDM Twice Daily
Comments Total Lesion Counts, WEEK 8
Type of Statistical Test Non-Inferiority or Equivalence
Comments If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -9.12
Confidence Interval (2-Sided) 95%
-13.82 to -4.43
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection GSK2585823 Once Daily, CLDM Twice Daily
Comments Total Lesion Counts, WEEK 12
Type of Statistical Test Non-Inferiority or Equivalence
Comments If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -9.43
Confidence Interval (2-Sided) 95%
-14.11 to -4.75
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection GSK2585823 Once Daily, CLDM Twice Daily
Comments Inflammatory Lesion Counts, WEEK 1
Type of Statistical Test Non-Inferiority or Equivalence
Comments If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -10.54
Confidence Interval (2-Sided) 95%
-15.12 to -5.97
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection GSK2585823 Once Daily, CLDM Twice Daily
Comments Inflammatory Lesion Counts, WEEK 2
Type of Statistical Test Non-Inferiority or Equivalence
Comments If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -7.21
Confidence Interval (2-Sided) 95%
-12.73 to -1.69
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection GSK2585823 Once Daily, CLDM Twice Daily
Comments Inflammatory Lesion Counts, WEEK 4
Type of Statistical Test Non-Inferiority or Equivalence
Comments If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -7.64
Confidence Interval (2-Sided) 95%
-12.93 to -2.35
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection GSK2585823 Once Daily, CLDM Twice Daily
Comments Inflammatory Lesion Counts, WEEK 8
Type of Statistical Test Non-Inferiority or Equivalence
Comments If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -8.73
Confidence Interval (2-Sided) 95%
-14.20 to -3.26
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection GSK2585823 Once Daily, CLDM Twice Daily
Comments Inflammatory Lesion Counts, WEEK 12
Type of Statistical Test Non-Inferiority or Equivalence
Comments If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -8.20
Confidence Interval (2-Sided) 95%
-13.34 to -3.06
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection GSK2585823 Once Daily, CLDM Twice Daily
Comments Non-Inflammatory Lesion Counts, WEEK 1
Type of Statistical Test Non-Inferiority or Equivalence
Comments If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -5.80
Confidence Interval (2-Sided) 95%
-10.29 to -1.32
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection GSK2585823 Once Daily, CLDM Twice Daily
Comments Non-Inflammatory Lesion Counts, WEEK 2
Type of Statistical Test Non-Inferiority or Equivalence
Comments If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -8.30
Confidence Interval (2-Sided) 95%
-14.10 to -2.50
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection GSK2585823 Once Daily, CLDM Twice Daily
Comments Non-Inflammatory Lesion Counts, WEEK 4
Type of Statistical Test Non-Inferiority or Equivalence
Comments If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -9.27
Confidence Interval (2-Sided) 95%
-14.72 to -3.83
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection GSK2585823 Once Daily, CLDM Twice Daily
Comments Non-Inflammatory Lesion Counts, WEEK 8
Type of Statistical Test Non-Inferiority or Equivalence
Comments If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -8.84
Confidence Interval (2-Sided) 95%
-14.28 to -3.39
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection GSK2585823 Once Daily, CLDM Twice Daily
Comments Non-Inflammatory Lesion Counts, WEEK 12
Type of Statistical Test Non-Inferiority or Equivalence
Comments If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -9.68
Confidence Interval (2-Sided) 95%
-15.06 to -4.30
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection GSK2585823 Twice Daily, CLDM Twice Daily
Comments Total Lesion Counts, WEEK 1
Type of Statistical Test Superiority
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 (Net)
Estimated Value -8.90
Confidence Interval (2-Sided) 95%
-12.32 to -5.48
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection GSK2585823 Twice Daily, CLDM Twice Daily
Comments Total Lesion Counts, WEEK 2
Type of Statistical Test Superiority
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 (Net)
Estimated Value -11.17
Confidence Interval (2-Sided) 95%
-15.18 to -7.16
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection GSK2585823 Twice Daily, CLDM Twice Daily
Comments Total Lesion Counts, WEEK 4
Type of Statistical Test Superiority
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 (Net)
Estimated Value -12.12
Confidence Interval (2-Sided) 95%
-15.90 to -8.35
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection GSK2585823 Twice Daily, CLDM Twice Daily
Comments Total Lesion Counts, WEEK 8
Type of Statistical Test Superiority
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 (Net)
Estimated Value -11.33
Confidence Interval (2-Sided) 95%
-15.37 to -7.30
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection GSK2585823 Twice Daily, CLDM Twice Daily
Comments Total Lesion Counts, WEEK 12
Type of Statistical Test Superiority
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 (Net)
Estimated Value -11.18
Confidence Interval (2-Sided) 95%
-15.11 to -7.25
Estimation Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection GSK2585823 Twice Daily, CLDM Twice Daily
Comments Inflammatory Lesion Counts, WEEK 1
Type of Statistical Test Superiority
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 (Net)
Estimated Value -8.32
Confidence Interval (2-Sided) 95%
-12.76 to -3.88
Estimation Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection GSK2585823 Twice Daily, CLDM Twice Daily
Comments Inflammatory Lesion Counts, WEEK 2
Type of Statistical Test Superiority
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 (Net)
Estimated Value -9.57
Confidence Interval (2-Sided) 95%
-13.83 to -5.30
Estimation Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection GSK2585823 Twice Daily, CLDM Twice Daily
Comments Inflammatory Lesion Counts, WEEK 4
Type of Statistical Test Superiority
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 (Net)
Estimated Value -7.83
Confidence Interval (2-Sided) 95%
-12.03 to -3.62
Estimation Comments [Not Specified]
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection GSK2585823 Twice Daily, CLDM Twice Daily
Comments Inflammatory Lesion Counts, WEEK 8
Type of Statistical Test Superiority
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 (Net)
Estimated Value -8.08
Confidence Interval (2-Sided) 95%
-12.63 to -3.53
Estimation Comments [Not Specified]
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection GSK2585823 Twice Daily, CLDM Twice Daily
Comments Inflammatory Lesion Counts, WEEK 12
Type of Statistical Test Superiority
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 (Net)
Estimated Value -8.56
Confidence Interval (2-Sided) 95%
-12.71 to -4.41
Estimation Comments [Not Specified]
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection GSK2585823 Twice Daily, CLDM Twice Daily
Comments Non-Inflammatory Lesion Counts, WEEK 1
Type of Statistical Test Superiority
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 (Net)
Estimated Value -9.11
Confidence Interval (2-Sided) 95%
-13.53 to -4.68
Estimation Comments [Not Specified]
Show Statistical Analysis 27 Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection GSK2585823 Twice Daily, CLDM Twice Daily
Comments Non-Inflammatory Lesion Counts, WEEK 2
Type of Statistical Test Superiority
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 (Net)
Estimated Value -11.05
Confidence Interval (2-Sided) 95%
-16.30 to -5.80
Estimation Comments [Not Specified]
Show Statistical Analysis 28 Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection GSK2585823 Twice Daily, CLDM Twice Daily
Comments Non-Inflammatory Lesion Counts, WEEK 4
Type of Statistical Test Superiority
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 (Net)
Estimated Value -14.17
Confidence Interval (2-Sided) 95%
-18.97 to -9.37
Estimation Comments [Not Specified]
Show Statistical Analysis 29 Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection GSK2585823 Twice Daily, CLDM Twice Daily
Comments Non-Inflammatory Lesion Counts, WEEK 8
Type of Statistical Test Superiority
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 (Net)
Estimated Value -13.04
Confidence Interval (2-Sided) 95%
-17.83 to -8.25
Estimation Comments [Not Specified]
Show Statistical Analysis 30 Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection GSK2585823 Twice Daily, CLDM Twice Daily
Comments Non-Inflammatory Lesion Counts, WEEK 12
Type of Statistical Test Superiority
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 (Net)
Estimated Value -12.37
Confidence Interval (2-Sided) 95%
-17.05 to -7.68
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With a Minimum 2-grade Improvement From Baseline to Week 12 in Investigator’s Static Global Assessment (ISGA) Score
Hide Description Proportion of participants with at least a 2-Grade Improvement in ISGA was reported using a 5 point scale which indicates Score 0 (Clear): skin with no inflammatory or non-inflammatory lesions, Score 1 (Almost Clear): rare non-inflammatory lesions with no more than rare papules, Score 2 (Mild): greater than Grade 1, some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions), Score 3 (Moderate): greater than Grade 2, many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion, Score 4 (Severe): greater than Grade 3, many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions and 5(very severe): many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions. The investigator assessed ISGA score at baseline (Week 0/Day 1) and Weeks 1, 2, 4, 8, and 12. The area evaluated ISGA was limited to the face.
Time Frame Baseline (Day 1) and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Only those participants available at the indicated time points were analyzed.
Arm/Group Title GSK2585823 Once Daily GSK2585823 Twice Daily CLDM Twice Daily
Hide Arm/Group Description:
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Overall Number of Participants Analyzed 184 262 290
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
30
(23.4 to 37.1)
31
(25.7 to 37.3)
14
(10.6 to 19.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK2585823 Twice Daily, CLDM Twice Daily
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]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GSK2585823 Once Daily, CLDM Twice Daily
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]
6.Secondary Outcome
Title Percentage of Participants With an ISGA Score of 0 (Clear) or 1 (Almost Clear) at Weeks 1, 2, 4, 8, and 12
Hide Description Proportion of participants with at least a 2-Grade Improvement in ISGA was reported using a 5 point scale which indicates Score 0 (Clear): skin with no inflammatory or non-inflammatory lesions, Score 1 (Almost Clear): rare non-inflammatory lesions with no more than rare papules, Score 2 (Mild): greater than Grade 1, some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions), Score 3 (Moderate): greater than Grade 2, many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion, Score 4 (Severe): greater than Grade 3, many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions and 5 (very severe): many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions. The investigator assessed ISGA score at baseline (Week 0/Day 1) and Weeks 1, 2, 4, 8, and 12. The area evaluated ISGA was limited to the face.
Time Frame Week 1, 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles).
Arm/Group Title GSK2585823 Once Daily GSK2585823 Twice Daily CLDM Twice Daily
Hide Arm/Group Description:
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Overall Number of Participants Analyzed 204 296 299
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 1 Number Analyzed 200 participants 287 participants 295 participants
2
(0.5 to 5.0)
2
(0.8 to 4.5)
1
(0.4 to 3.4)
Week 2 Number Analyzed 197 participants 281 participants 297 participants
7
(3.9 to 11.6)
5
(2.5 to 7.8)
5
(2.9 to 8.2)
Week 4 Number Analyzed 191 participants 269 participants 296 participants
11
(6.9 to 16.3)
13
(9.2 to 17.6)
7
(4.7 to 11.0)
Week 8 Number Analyzed 186 participants 260 participants 292 participants
22
(15.8 to 28.1)
20
(15.3 to 25.4)
9
(5.9 to 12.8)
Week 12 Number Analyzed 184 participants 262 participants 290 participants
30
(23.4 to 37.1)
34
(27.9 to 39.7)
20
(15.2 to 24.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK2585823 Twice Daily, CLDM Twice Daily
Comments Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.470
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GSK2585823 Twice Daily, CLDM Twice Daily
Comments Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.844
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GSK2585823 Twice Daily, CLDM Twice Daily
Comments Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GSK2585823 Twice Daily, CLDM Twice Daily
Comments Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 8
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]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection GSK2585823 Twice Daily, CLDM Twice Daily
Comments Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 12
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]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection GSK2585823 Once Daily, CLDM Twice Daily
Comments Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.572
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection GSK2585823 Once Daily, CLDM Twice Daily
Comments Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.335
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection GSK2585823 Once Daily, CLDM Twice Daily
Comments Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.187
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection GSK2585823 Once Daily, CLDM Twice Daily
Comments Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 8
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]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection GSK2585823 Once Daily, CLDM Twice Daily
Comments Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants Who Have a Reduction of at Least 50 Percent in Total Lesions
Hide Description The percentage of participants who had reduction in total lesions (inflammatory and non-inflammatory) of at least 50 percent from Baseline at Weeks 1, 2, 4, 8, and 12 was measured.
Time Frame Baseline (Day 1) and Week 1, 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Only those participants available at the indicated time points were analyzed.
Arm/Group Title GSK2585823 Once Daily GSK2585823 Twice Daily CLDM Twice Daily
Hide Arm/Group Description:
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Overall Number of Participants Analyzed 204 296 299
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 1 Number Analyzed 200 participants 287 participants 295 participants
18
(12.5 to 23.5)
24
(19.5 to 29.8)
15
(11.1 to 19.5)
Week 2 Number Analyzed 201 participants 289 participants 299 participants
47
(40.2 to 54.4)
51
(44.9 to 56.8)
32
(26.5 to 37.4)
Week 4 Number Analyzed 201 participants 289 participants 299 participants
63
(55.6 to 69.4)
71
(65.3 to 76.1)
52
(45.7 to 57.3)
Week 8 Number Analyzed 201 participants 289 participants 299 participants
79
(72.8 to 84.5)
82
(77.1 to 86.3)
69
(63.0 to 73.8)
Week 12 Number Analyzed 201 participants 289 participants 299 participants
85
(79.4 to 89.7)
89
(84.3 to 92.0)
79
(73.5 to 83.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK2585823 Twice Daily, CLDM Twice Daily
Comments Comparison of GSK2585823 twice daily and CLDM twice daily at Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GSK2585823 Twice Daily, CLDM Twice Daily
Comments Comparison of GSK2585823 twice daily and CLDM twice daily at Week 2
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]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GSK2585823 Twice Daily, CLDM Twice Daily
Comments Comparison of GSK2585823 twice daily and CLDM twice daily at Week 4
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]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GSK2585823 Twice Daily, CLDM Twice Daily
Comments Comparison of GSK2585823 twice daily and CLDM twice daily at Week 8
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]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection GSK2585823 Twice Daily, CLDM Twice Daily
Comments Comparison of GSK2585823 twice daily and CLDM twice daily at Week 12
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]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection GSK2585823 Once Daily, CLDM Twice Daily
Comments Comparison of GSK2585823 once daily and CLDM twice daily at Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.480
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection GSK2585823 Once Daily, CLDM Twice Daily
Comments Comparison of GSK2585823 once daily and CLDM twice daily at Week 2
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]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection GSK2585823 Once Daily, CLDM Twice Daily
Comments Comparison of GSK2585823 once daily and CLDM twice daily at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection GSK2585823 Once Daily, CLDM Twice Daily
Comments Comparison of GSK2585823 once daily and CLDM twice daily at Week 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection GSK2585823 Once Daily, CLDM Twice Daily
Comments Comparison of GSK2585823 once daily and CLDM twice daily at Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.065
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
8.Secondary Outcome
Title Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX)
Hide Description MIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism). MIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism) for the susceptibility of clinical isolates (Propionibacterium acnes before and after application of the CLDM and NDFX was reported. MIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis.
Time Frame Baseline (Day 1) and Week12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles).
Arm/Group Title GSK2585823 Once Daily GSK2585823 Twice Daily CLDM Twice Daily
Hide Arm/Group Description:
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Overall Number of Participants Analyzed 204 296 299
Measure Type: Number
Unit of Measure: Micrograms/milliliter
CLDM,Baseline,MIC50 Number Analyzed 154 participants 225 participants 220 participants
0.12 0.12 0.12
CLDM,Baseline,MIC90 Number Analyzed 154 participants 225 participants 220 participants
1 4 4
CLDM, Week 12,MIC50 Number Analyzed 12 participants 22 participants 59 participants
0.25 0.5 0.5
CLDM, Week 12,MIC90 Number Analyzed 12 participants 22 participants 59 participants
128 128 128
NDFX,Baseline,MIC50 Number Analyzed 154 participants 225 participants 220 participants
0.25 0.25 0.25
NDFX,Baseline,MIC90 Number Analyzed 154 participants 225 participants 220 participants
0.5 0.5 0.5
NDFX, Week 12,MIC50 Number Analyzed 12 participants 22 participants 59 participants
0.25 0.25 0.25
NDFX, Week 12,MIC90 Number Analyzed 12 participants 22 participants 59 participants
0.5 0.5 0.5
9.Secondary Outcome
Title Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12
Hide Description Erythema (redness), dryness, and peeling, were evaluated independently by the investigator on a five point scale from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Day 1 was Baseline and Change from Baseline was calculated by subtracting Baseline value from value at specified time points (Week 1, 2, 4, 8, and 12).
Time Frame Baseline (Day 1) and Week 1, 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles).
Arm/Group Title GSK2585823 Once Daily GSK2585823 Twice Daily CLDM Twice Daily
Hide Arm/Group Description:
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Overall Number of Participants Analyzed 204 296 299
Mean (Standard Deviation)
Unit of Measure: Score on scale
Erythema score-Week 1 Number Analyzed 198 participants 285 participants 298 participants
-0.11  (0.58) -0.00  (0.63) -0.11  (0.52)
Erythema score-Week 2 Number Analyzed 192 participants 275 participants 297 participants
-0.16  (0.76) -0.02  (0.82) -0.19  (0.58)
Erythema score-Week 4 Number Analyzed 187 participants 266 participants 294 participants
-0.30  (0.72) -0.24  (0.75) -0.27  (0.62)
Erythema score-Week 8 Number Analyzed 185 participants 262 participants 291 participants
-0.43  (0.82) -0.33  (0.78) -0.31  (0.67)
Erythema score-Week 12 Number Analyzed 183 participants 262 participants 290 participants
-0.49  (0.82) -0.45  (0.87) -0.38  (0.75)
Dryness yscore-Week 1 Number Analyzed 198 participants 285 participants 298 participants
0.10  (0.65) 0.29  (0.76) -0.04  (0.47)
Dryness score-Week 2 Number Analyzed 192 participants 275 participants 297 participants
0.04  (0.65) 0.23  (0.80) -0.11  (0.51)
Dryness score-Week 4 Number Analyzed 187 participants 266 participants 294 participants
-0.06  (0.57) 0.00  (0.65) -0.15  (0.53)
Dryness score-Week 8 Number Analyzed 185 participants 262 participants 291 participants
-0.11  (0.61) -0.00  (0.67) -0.13  (0.50)
Dryness score-Week 12 Number Analyzed 183 participants 262 participants 290 participants
-0.18  (0.62) -0.10  (0.61) -0.17  (0.52)
Peeling score-Week 1 Number Analyzed 198 participants 285 participants 298 participants
0.09  (0.50) 0.19  (0.68) -0.04  (0.39)
Peeling score-Week 2 Number Analyzed 192 participants 275 participants 297 participants
0.02  (0.49) 0.17  (0.68) -0.10  (0.39)
Peeling score-Week 4 Number Analyzed 187 participants 266 participants 294 participants
-0.05  (0.44) 0.04  (0.54) -0.14  (0.43)
Peeling score-Week 8 Number Analyzed 185 participants 262 participants 291 participants
-0.08  (0.46) 0.03  (0.56) -0.13  (0.43)
Peeling score-Week 12 Number Analyzed 183 participants 262 participants 290 participants
-0.08  (0.49) -0.07  (0.51) -0.13  (0.44)
10.Secondary Outcome
Title Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12
Hide Description Burning/stinging, itching were evaluated independently by the participant on a five point scale from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Day 1 was Baseline and Change from Baseline was calculated by subtracting Baseline value from value at specified time points (Week 1, 2, 4, 8, and 12).
Time Frame Baseline (Day 1) and Week 1, 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Only those participants available at the specified time points were analyzed (represented by n=X. X, X in the category titles).
Arm/Group Title GSK2585823 Once Daily GSK2585823 Twice Daily CLDM Twice Daily
Hide Arm/Group Description:
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Overall Number of Participants Analyzed 204 296 299
Mean (Standard Deviation)
Unit of Measure: Score on scale
Itching Score, Week 1 Number Analyzed 198 participants 285 participants 298 participants
-0.02  (0.53) 0.07  (0.61) -0.08  (0.53)
Itching Score, Week 2 Number Analyzed 192 participants 275 participants 297 participants
-0.06  (0.58) 0.12  (0.73) -0.13  (0.48)
Itching Score, Week 4 Number Analyzed 187 participants 266 participants 294 participants
-0.10  (0.51) -0.02  (0.48) -0.14  (0.51)
Itching Score, Week 8 Number Analyzed 185 participants 262 participants 291 participants
-0.15  (0.50) -0.06  (0.43) -0.14  (0.55)
Itching Score, Week 12 Number Analyzed 183 participants 262 participants 290 participants
-0.10  (0.59) -0.08  (0.53) -0.12  (0.52)
Burning/Stinging Score, Week 1 Number Analyzed 198 participants 285 participants 298 participants
0.08  (0.55) 0.26  (0.76) -0.02  (0.45)
Burning/Stinging Score, Week 2 Number Analyzed 192 participants 275 participants 297 participants
0.02  (0.45) 0.11  (0.61) -0.06  (0.37)
Burning/Stinging Score, Week 4 Number Analyzed 187 participants 266 participants 294 participants
-0.02  (0.43) -0.02  (0.48) -0.07  (0.39)
Burning/Stinging Score, Week 8 Number Analyzed 185 participants 262 participants 291 participants
-0.02  (0.44) -0.04  (0.47) -0.08  (0.39)
Burning/Stinging Score, Week 12 Number Analyzed 183 participants 262 participants 290 participants
-0.06  (0.38) -0.08  (0.38) -0.08  (0.37)
Time Frame Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
Adverse Event Reporting Description ITT population was used.
 
Arm/Group Title GSK2585823 Once Daily GSK2585823 Twice Daily CLDM Twice Daily
Hide Arm/Group Description Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU. Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU. Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
All-Cause Mortality
GSK2585823 Once Daily GSK2585823 Twice Daily CLDM Twice Daily
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/204 (0.00%)   0/296 (0.00%)   0/299 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
GSK2585823 Once Daily GSK2585823 Twice Daily CLDM Twice Daily
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/204 (0.00%)   0/296 (0.00%)   0/299 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
GSK2585823 Once Daily GSK2585823 Twice Daily CLDM Twice Daily
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   108/204 (52.94%)   163/296 (55.07%)   110/299 (36.79%) 
Blood and lymphatic system disorders       
Leukopenia  1  0/204 (0.00%)  0/296 (0.00%)  1/299 (0.33%) 
Cardiac disorders       
Tachycardia  1  0/204 (0.00%)  0/296 (0.00%)  1/299 (0.33%) 
Eye disorders       
Eyelid oedema  1  2/204 (0.98%)  2/296 (0.68%)  0/299 (0.00%) 
Erythema of eyelid  1  1/204 (0.49%)  2/296 (0.68%)  0/299 (0.00%) 
Blepharitis  1  1/204 (0.49%)  1/296 (0.34%)  0/299 (0.00%) 
Conjunctivitis  1  0/204 (0.00%)  1/296 (0.34%)  1/299 (0.33%) 
Eyelid irritation  1  0/204 (0.00%)  2/296 (0.68%)  0/299 (0.00%) 
Conjunctivitis allergic  1  0/204 (0.00%)  0/296 (0.00%)  1/299 (0.33%) 
Eczema eyelids  1  0/204 (0.00%)  1/296 (0.34%)  0/299 (0.00%) 
Eye inflammation  1  0/204 (0.00%)  1/296 (0.34%)  0/299 (0.00%) 
Eyelids pruritus  1  0/204 (0.00%)  1/296 (0.34%)  0/299 (0.00%) 
Gastrointestinal disorders       
Diarrhoea  1  2/204 (0.98%)  1/296 (0.34%)  2/299 (0.67%) 
Abdominal pain  1  0/204 (0.00%)  0/296 (0.00%)  2/299 (0.67%) 
Abdominal pain upper  1  0/204 (0.00%)  0/296 (0.00%)  2/299 (0.67%) 
Aphthous stomatitis  1  0/204 (0.00%)  2/296 (0.68%)  0/299 (0.00%) 
Dental caries  1  1/204 (0.49%)  1/296 (0.34%)  0/299 (0.00%) 
Gastritis  1  0/204 (0.00%)  1/296 (0.34%)  1/299 (0.33%) 
Lip dry  1  0/204 (0.00%)  1/296 (0.34%)  0/299 (0.00%) 
Nausea  1  0/204 (0.00%)  0/296 (0.00%)  1/299 (0.33%) 
Proctitis  1  1/204 (0.49%)  0/296 (0.00%)  0/299 (0.00%) 
Radicular cyst  1  0/204 (0.00%)  0/296 (0.00%)  1/299 (0.33%) 
Stomatitis  1  0/204 (0.00%)  0/296 (0.00%)  1/299 (0.33%) 
Toothache  1  0/204 (0.00%)  1/296 (0.34%)  0/299 (0.00%) 
Vomiting  1  1/204 (0.49%)  0/296 (0.00%)  0/299 (0.00%) 
General disorders       
Facial pain  1  9/204 (4.41%)  9/296 (3.04%)  4/299 (1.34%) 
Pyrexia  1  2/204 (0.98%)  0/296 (0.00%)  1/299 (0.33%) 
Feeling hot  1  0/204 (0.00%)  1/296 (0.34%)  0/299 (0.00%) 
Nodule  1  0/204 (0.00%)  1/296 (0.34%)  0/299 (0.00%) 
Immune system disorders       
Seasonal allergy  1  0/204 (0.00%)  1/296 (0.34%)  0/299 (0.00%) 
Infections and infestations       
Nasopharyngitis  1  28/204 (13.73%)  48/296 (16.22%)  39/299 (13.04%) 
Influenza  1  4/204 (1.96%)  9/296 (3.04%)  7/299 (2.34%) 
Gastroenteritis  1  3/204 (1.47%)  2/296 (0.68%)  0/299 (0.00%) 
Oral herpes  1  2/204 (0.98%)  0/296 (0.00%)  1/299 (0.33%) 
Pneumonia mycoplasmal  1  2/204 (0.98%)  0/296 (0.00%)  1/299 (0.33%) 
Herpes zoster  1  0/204 (0.00%)  1/296 (0.34%)  1/299 (0.33%) 
Infected dermal cyst  1  2/204 (0.98%)  0/296 (0.00%)  0/299 (0.00%) 
Acute tonsillitis  1  0/204 (0.00%)  1/296 (0.34%)  0/299 (0.00%) 
Bronchitis  1  1/204 (0.49%)  0/296 (0.00%)  0/299 (0.00%) 
Enteritis infectious  1  0/204 (0.00%)  1/296 (0.34%)  0/299 (0.00%) 
Folliculitis  1  0/204 (0.00%)  0/296 (0.00%)  1/299 (0.33%) 
Hordeolum  1  0/204 (0.00%)  0/296 (0.00%)  1/299 (0.33%) 
Impetigo  1  0/204 (0.00%)  1/296 (0.34%)  0/299 (0.00%) 
Pericoronitis  1  0/204 (0.00%)  1/296 (0.34%)  0/299 (0.00%) 
Rhinitis  1  1/204 (0.49%)  0/296 (0.00%)  0/299 (0.00%) 
Skin infection  1  0/204 (0.00%)  0/296 (0.00%)  1/299 (0.33%) 
Tinea pedis  1  0/204 (0.00%)  0/296 (0.00%)  1/299 (0.33%) 
Upper respiratory tract infection  1  0/204 (0.00%)  1/296 (0.34%)  0/299 (0.00%) 
Varicella  1  1/204 (0.49%)  0/296 (0.00%)  0/299 (0.00%) 
Vulvovaginal candidiasis  1  1/204 (0.49%)  0/296 (0.00%)  0/299 (0.00%) 
Injury, poisoning and procedural complications       
Thermal burn  1  2/204 (0.98%)  2/296 (0.68%)  2/299 (0.67%) 
Contusion  1  1/204 (0.49%)  1/296 (0.34%)  3/299 (1.00%) 
Ligament sprain  1  1/204 (0.49%)  3/296 (1.01%)  0/299 (0.00%) 
Arthropod bite  1  1/204 (0.49%)  0/296 (0.00%)  2/299 (0.67%) 
Excoriation  1  0/204 (0.00%)  0/296 (0.00%)  2/299 (0.67%) 
Arthropod sting  1  1/204 (0.49%)  0/296 (0.00%)  0/299 (0.00%) 
Eye injury  1  1/204 (0.49%)  0/296 (0.00%)  0/299 (0.00%) 
Fractured coccyx  1  1/204 (0.49%)  0/296 (0.00%)  0/299 (0.00%) 
Hand fracture  1  0/204 (0.00%)  0/296 (0.00%)  1/299 (0.33%) 
Laceration  1  0/204 (0.00%)  1/296 (0.34%)  0/299 (0.00%) 
Muscle strain  1  0/204 (0.00%)  0/296 (0.00%)  1/299 (0.33%) 
Investigations       
Alanine aminotransferase increased  1  3/204 (1.47%)  0/296 (0.00%)  5/299 (1.67%) 
Aspartate aminotransferase increased  1  3/204 (1.47%)  1/296 (0.34%)  4/299 (1.34%) 
Blood bilirubin increased  1  1/204 (0.49%)  2/296 (0.68%)  5/299 (1.67%) 
White blood cell count increased  1  1/204 (0.49%)  3/296 (1.01%)  1/299 (0.33%) 
Gamma-glutamyltransferase increased  1  0/204 (0.00%)  0/296 (0.00%)  4/299 (1.34%) 
Glucose urine present  1  1/204 (0.49%)  1/296 (0.34%)  2/299 (0.67%) 
Protein urine present  1  2/204 (0.98%)  0/296 (0.00%)  2/299 (0.67%) 
Blood alkaline phosphatase increased  1  0/204 (0.00%)  0/296 (0.00%)  1/299 (0.33%) 
Blood lactate dehydrogenase increased  1  0/204 (0.00%)  0/296 (0.00%)  1/299 (0.33%) 
White blood cell count decreased  1  0/204 (0.00%)  1/296 (0.34%)  0/299 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  0/204 (0.00%)  1/296 (0.34%)  0/299 (0.00%) 
Neck pain  1  1/204 (0.49%)  0/296 (0.00%)  0/299 (0.00%) 
Plantar fasciitis  1  0/204 (0.00%)  1/296 (0.34%)  0/299 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Skin papilloma  1  0/204 (0.00%)  1/296 (0.34%)  2/299 (0.67%) 
Nervous system disorders       
Burning sensation  1  6/204 (2.94%)  12/296 (4.05%)  4/299 (1.34%) 
Headache  1  2/204 (0.98%)  3/296 (1.01%)  0/299 (0.00%) 
Dizziness postural  1  1/204 (0.49%)  0/296 (0.00%)  0/299 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Asthma  1  0/204 (0.00%)  1/296 (0.34%)  0/299 (0.00%) 
Oropharyngeal pain  1  1/204 (0.49%)  0/296 (0.00%)  0/299 (0.00%) 
Rhinitis allergic  1  0/204 (0.00%)  1/296 (0.34%)  0/299 (0.00%) 
Upper respiratory tract inflammation  1  1/204 (0.49%)  0/296 (0.00%)  0/299 (0.00%) 
Skin and subcutaneous tissue disorders       
Dry skin  1  17/204 (8.33%)  35/296 (11.82%)  8/299 (2.68%) 
Dermatitis contact  1  14/204 (6.86%)  24/296 (8.11%)  5/299 (1.67%) 
Erythema  1  8/204 (3.92%)  22/296 (7.43%)  8/299 (2.68%) 
Pruritus  1  9/204 (4.41%)  17/296 (5.74%)  6/299 (2.01%) 
Skin exfoliation  1  4/204 (1.96%)  25/296 (8.45%)  2/299 (0.67%) 
Eczema  1  4/204 (1.96%)  10/296 (3.38%)  7/299 (2.34%) 
Dermatitis exfoliative  1  4/204 (1.96%)  6/296 (2.03%)  4/299 (1.34%) 
Skin irritation  1  3/204 (1.47%)  8/296 (2.70%)  2/299 (0.67%) 
Acne  1  3/204 (1.47%)  4/296 (1.35%)  2/299 (0.67%) 
Urticaria  1  3/204 (1.47%)  3/296 (1.01%)  0/299 (0.00%) 
Eczema asteatotic  1  1/204 (0.49%)  3/296 (1.01%)  1/299 (0.33%) 
Dermatitis  1  1/204 (0.49%)  3/296 (1.01%)  0/299 (0.00%) 
Dermatitis atopic  1  0/204 (0.00%)  0/296 (0.00%)  2/299 (0.67%) 
Dyshidrosis  1  1/204 (0.49%)  1/296 (0.34%)  0/299 (0.00%) 
Solar dermatitis  1  0/204 (0.00%)  1/296 (0.34%)  1/299 (0.33%) 
Swelling face  1  1/204 (0.49%)  1/296 (0.34%)  0/299 (0.00%) 
Xeroderma  1  0/204 (0.00%)  1/296 (0.34%)  1/299 (0.33%) 
Asteatosis  1  0/204 (0.00%)  0/296 (0.00%)  1/299 (0.33%) 
Dandruff  1  0/204 (0.00%)  1/296 (0.34%)  0/299 (0.00%) 
Eczema nummular  1  1/204 (0.49%)  0/296 (0.00%)  0/299 (0.00%) 
Hyperkeratosis  1  0/204 (0.00%)  1/296 (0.34%)  0/299 (0.00%) 
Nail disorder  1  1/204 (0.49%)  0/296 (0.00%)  0/299 (0.00%) 
Pityriasis  1  0/204 (0.00%)  1/296 (0.34%)  0/299 (0.00%) 
Rash maculo-papular  1  0/204 (0.00%)  0/296 (0.00%)  1/299 (0.33%) 
Seborrhoeic dermatitis  1  1/204 (0.49%)  0/296 (0.00%)  0/299 (0.00%) 
1
Term from vocabulary, MedDRA 15.0
Indicates events were collected by systematic assessment
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
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01445301     History of Changes
Other Study ID Numbers: 115287
First Submitted: September 15, 2011
First Posted: October 3, 2011
Results First Submitted: April 11, 2017
Results First Posted: April 27, 2018
Last Update Posted: April 27, 2018