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Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With Acne

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00776919
Recruitment Status : Completed
First Posted : October 22, 2008
Results First Posted : January 30, 2012
Last Update Posted : November 23, 2016
Sponsor:
Collaborators:
Rho, Inc.
Quintiles, Inc.
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: clindamycin / benzoyl peroxide gel
Drug: clindamycin gel
Drug: BPO gel
Drug: vehicle gel
Enrollment 1315
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Duac Low-dose (LD) Gel Clindamycin Gel BPO Gel Vehicle Gel
Hide Arm/Group Description Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Period Title: Overall Study
Started 327 328 328 332
Completed 300 295 296 293
Not Completed 27 33 32 39
Reason Not Completed
Withdrawal by Subject             16             14             15             26
Lost to Follow-up             8             12             11             8
Adverse Event             1             0             2             2
Protocol Violation             1             2             0             1
Other: Lack of Efficacy/Lost Medication             1             5             4             2
Arm/Group Title Duac Low-dose (LD) Gel Clindamycin Gel BPO Gel Vehicle Gel Total
Hide Arm/Group Description Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 327 328 328 332 1315
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 327 participants 328 participants 328 participants 332 participants 1315 participants
20.0  (7.0) 20.2  (6.9) 20.6  (7.1) 20.7  (7.4) 20.4  (7.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 327 participants 328 participants 328 participants 332 participants 1315 participants
Female
202
  61.8%
180
  54.9%
203
  61.9%
210
  63.3%
795
  60.5%
Male
125
  38.2%
148
  45.1%
125
  38.1%
122
  36.7%
520
  39.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 327 participants 328 participants 328 participants 332 participants 1315 participants
White 259 274 251 258 1042
Black 47 37 54 54 192
Asian 13 9 17 16 55
Multiracial 5 7 7 4 23
American Indian or Alaska Native 3 1 0 0 4
1.Primary Outcome
Title Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12
Hide Description During each study visit, investigators/assessors evaluated acne severity of the participants' faces using the ISGA scale: 0=clear skin with no lesions (L); 1=almost clear, rare non-inflammatory L; 2=mild, some non-inflammatory L with no more than a few inflammatory L, no nodular L; 3=moderate, many non-inflammatory L, may have some inflammatory L, but no more than 1 small nodular L; 4=severe, many non-inflammatory and inflammatory L, but no more than a few nodular L; 5=very severe, many non-inflammatory and inflammatory L, and more than a few nodular L.
Time Frame Baseline (Day 1) and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all participants who were randomized to and received at least 1 application of study product. Participants with missing Week 12 evaluations were considered failures. Failures are defined as those participants with a 1-grade improvement, no improvement, or a worsening.
Arm/Group Title Duac Low-dose (LD) Gel Clindamycin Gel BPO Gel Vehicle Gel
Hide Arm/Group Description:
Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Overall Number of Participants Analyzed 327 328 328 332
Measure Type: Number
Unit of Measure: participants
129 82 100 59
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duac Low-dose (LD) Gel, Clindamycin 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]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Duac Low-dose (LD) Gel, BPO Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duac Low-dose (LD) Gel, Vehicle 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]
2.Primary Outcome
Title Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts
Hide Description During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules [small inflamed elevation of the skin that is filled with pus], papules [solid elevation of skin with no visible fluid], nodules [larger than papules with significant depth]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin). Missing values were imputed using the last observation carried forward (LOCF) method.
Time Frame Baseline (Day 1) and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants who missed >=16 days of treatment or reported lost medication and never began treatment were excluded from the analysis. In the LOCF method, the last available observation, including BL, was used to estimate subsequent missing data points.
Arm/Group Title Duac Low-dose (LD) Gel Clindamycin Gel BPO Gel Vehicle Gel
Hide Arm/Group Description:
Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Overall Number of Participants Analyzed 322 318 323 329
Mean (Standard Deviation)
Unit of Measure: lesion counts
-18.2  (10.4) -15.6  (11.6) -16.8  (11.5) -13.1  (12.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duac Low-dose (LD) Gel, Clindamycin Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Duac Low-dose (LD) Gel, BPO Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duac Low-dose (LD) Gel, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.
Method ANCOVA
Comments [Not Specified]
3.Primary Outcome
Title Mean Change From Baseline to Week 12 in Non-inflammatory Lesion Counts
Hide Description During each study visit, trained study personnel at every investigational center assessed the non-inflammatory (open comedones [blackheads] and closed comedones [whiteheads]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin).
Time Frame Baseline (Day 1) and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants who missed >=16 days of treatment or who reported they had lost their medication and never began treatment were excluded from the analysis. Missing values for all other participants were imputed using the LOCF method.
Arm/Group Title Duac Low-dose (LD) Gel Clindamycin Gel BPO Gel Vehicle Gel
Hide Arm/Group Description:
Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Overall Number of Participants Analyzed 322 318 323 329
Mean (Standard Deviation)
Unit of Measure: lesion counts
-24.8  (20.1) -19.8  (19.8) -22.2  (17.6) -14.8  (21.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duac Low-dose (LD) Gel, Clindamycin Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Duac Low-dose (LD) Gel, BPO Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.102
Comments Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duac Low-dose (LD) Gel, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.
Method ANCOVA
Comments [Not Specified]
4.Primary Outcome
Title Mean Change From Baseline to Week 12 in Total Lesion Counts
Hide Description During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules, papules, nodules) and non-inflammatory (open and closed comedones) lesion counts for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face (including forehead, nose, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts.
Time Frame Baseline (Day 1) and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants who missed >=16 days of treatment or who reported they had lost their medication and never began treatment were excluded from the analysis. Missing values for all other participants were imputed using the LOCF method.
Arm/Group Title Duac Low-dose (LD) Gel Clindamycin Gel BPO Gel Vehicle Gel
Hide Arm/Group Description:
Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Overall Number of Participants Analyzed 322 318 323 329
Mean (Standard Deviation)
Unit of Measure: lesion counts
-43.0  (27.1) -35.5  (27.1) -39.0  (25.0) -27.8  (29.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duac Low-dose (LD) Gel, Clindamycin Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Duac Low-dose (LD) Gel, BPO Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.032
Comments Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duac Low-dose (LD) Gel, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.
Method ANCOVA
Comments [Not Specified]
5.Secondary Outcome
Title Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory)
Hide Description During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules, papules, nodules) and non-inflammatory (open and closed comedones) lesion counts for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face (including forehead, nose, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to Week 12 was calculated as the value at Week 12 minus the value at Baseline divided by the Baseline value * 100.
Time Frame Baseline (Day 1) and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants who missed >=16 days of treatment or who reported they had lost their medication and never began treatment were excluded from the analysis. Missing values for all other participants were imputed using the LOCF method.
Arm/Group Title Duac Low-dose (LD) Gel Clindamycin Gel BPO Gel Vehicle Gel
Hide Arm/Group Description:
Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Overall Number of Participants Analyzed 322 318 323 329
Mean (Standard Deviation)
Unit of Measure: Percent change in lesion counts
Inflammatory Lesions -68.9  (29.6) -58.1  (35.8) -61.8  (31.5) -48.8  (37.1)
Non-inflammatory Lesions -53.9  (32.2) -43.3  (39.6) -50.8  (33.5) -34.0  (47.2)
Total Lesions -59.8  (28.0) -49.2  (33.8) -55.5  (28.8) -40.4  (37.5)
6.Secondary Outcome
Title Number of Participants Who Had a Subject Global Assessment (SGA) Score of 0 or 1 at Week 12
Hide Description During each study visit, participants evaluated their facial acne (excluding the scalp) using the SGA scale: 0=free of acne, with only an occasional blackhead/whitehead; 1=several blackheads/whiteheads and small pimples, no tender deep-seated bumps/cysts; 2=several to many blackheads/whiteheads and small to medium-sized pimples, one deep-seated bump/cyst; 3=many blackheads/whiteheads, many medium- to large-sized pimples, few deep-seated bumps/cysts; 4=presence of blackheads/whiteheads, several to many medium- to large-sized pimples, deep-seated bumps/cysts dominate.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants with missing Week 12 evaluations were considered failures. Failures were defined as those participants with an SGA score >=2.
Arm/Group Title Duac Low-dose (LD) Gel Clindamycin Gel BPO Gel Vehicle Gel
Hide Arm/Group Description:
Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Overall Number of Participants Analyzed 327 328 328 332
Measure Type: Number
Unit of Measure: participants
209 171 189 154
7.Secondary Outcome
Title Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12
Hide Description During each study visit, investigators/assessors evaluated the acne severity of participants' faces using the ISGA scal: 0=clear skin with no lesions (L); 1=almost clear, rare non-inflammatory L; 2=mild, some non-inflammatory L with no more than a few inflammatory L, no nodular L; 3=moderate, many non-inflammatory L, may have some inflammatory L, but no more than 1 small nodular L; 4=severe, many non-inflammatory and inflammatory L, but no more than a few nodular L; 5=very severe, many non-inflammatory and inflammatory L, and more than a few nodular L.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants with missing Week 12 evaluations were considered failures. Failures were defined as those participants with an ISGA score >=2.
Arm/Group Title Duac Low-dose (LD) Gel Clindamycin Gel BPO Gel Vehicle Gel
Hide Arm/Group Description:
Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Overall Number of Participants Analyzed 327 328 328 332
Measure Type: Number
Unit of Measure: participants
148 91 116 81
8.Secondary Outcome
Title Mean Change From Baseline to Week 12 in Systolic and Diastolic Blood Pressure
Hide Description Systolic and diastolic blood pressure were measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.
Time Frame Baseline (Day 1) and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants with data available at both Baseline and Week 12 were analyzed.
Arm/Group Title Duac Low-dose (LD) Gel Clindamycin Gel BPO Gel Vehicle Gel
Hide Arm/Group Description:
Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Overall Number of Participants Analyzed 305 302 305 309
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury (mmHg)
Systolic blood pressure 0  (10) 0  (11) 0  (12) 0  (10)
Diastolic blood pressure 0  (8) 1  (9) 0  (8) 0  (8)
9.Secondary Outcome
Title Mean Change From Baseline to Week 12 in Temperature
Hide Description Temperature was measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.
Time Frame Baseline (Day 1) and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants with data available at both Baseline and Week 12 were analyzed.
Arm/Group Title Duac Low-dose (LD) Gel Clindamycin Gel BPO Gel Vehicle Gel
Hide Arm/Group Description:
Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Overall Number of Participants Analyzed 304 302 305 309
Mean (Standard Deviation)
Unit of Measure: Degrees centigrade
-0.1  (0.4) 0.0  (0.4) 0.0  (0.4) 0.0  (0.4)
10.Secondary Outcome
Title Mean Change From Baseline to Week 12 in Pulse Rate
Hide Description Pulse rate was measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.
Time Frame Baseline (Day 1) and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants with data available at both Baseline and Week 12 were analyzed.
Arm/Group Title Duac Low-dose (LD) Gel Clindamycin Gel BPO Gel Vehicle Gel
Hide Arm/Group Description:
Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Overall Number of Participants Analyzed 305 302 304 309
Mean (Standard Deviation)
Unit of Measure: Beats per minute (bpm)
1  (10) 2  (11) 2  (9) 2  (11)
11.Secondary Outcome
Title Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling
Hide Description Erythema (Er, redness), dryness (Dr), and peeling (Pn), were evaluated independently by the investigator as: 0 (absent)=no Er, Dr, or Pn; 1 (slight)=faint red/pink coloration (col.), barely perceptible Dr with no flakes or fissure, mild localized Pn; 2 (mild)=light red/pink col., perceptible Dr with no flakes/fissure, mild and diffuse Pn; 3 (moderate)=medium red col., easily noted Dr and flakes but no fissure; 4 (severe)=beet red col., Dr with flakes and fissure, prominent dense Pn. Change from Baseline was calculated as the value at Weeks 2, 4, 8, and 12 minus the the value at Baseline.
Time Frame Baseline; Weeks 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants with data available at both Baseline and the indicated assessment week were analyzed.
Arm/Group Title Duac Low-dose (LD) Gel Clindamycin Gel BPO Gel Vehicle Gel
Hide Arm/Group Description:
Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Overall Number of Participants Analyzed 298 302 306 306
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Erythema, Week 2, n=298, 302, 306, 306 -0.05  (0.63) -0.01  (0.58) -0.07  (0.56) -0.02  (0.61)
Erythema, Week 4, n=298, 300, 299, 306 -0.07  (0.66) -0.07  (0.64) -0.08  (0.67) -0.06  (0.64)
Erythema, Week 8, n=297, 296, 294, 293 -0.12  (0.71) -0.08  (0.67) -0.15  (0.68) -0.08  (0.73)
Erythema, Week 12, n=297, 296, 296, 294 -0.17  (0.66) -0.18  (0.63) -0.17  (0.67) -0.13  (0.69)
Dryness, Week 2, n=298, 302, 306, 306 0.07  (0.54) 0.03  (0.48) 0.09  (0.61) 0.04  (0.50)
Dryness, Week 4, n=298, 300, 299, 306 0.05  (0.58) -0.02  (0.51) 0.08  (0.55) 0.00  (0.52)
Dryness, Week 8, n=297, 296, 294, 293 0.00  (0.53) -0.02  (0.58) 0.05  (0.57) 0.02  (0.56)
Dryness, Week 12, n=297, 296, 296, 294 -0.07  (0.62) -0.10  (0.53) -0.01  (0.57) -0.04  (0.55)
Peeling, Week 2, n=298, 302, 306, 306 0.03  (0.43) 0.02  (0.36) 0.08  (0.51) 0.02  (0.41)
Peeling, Week 4, n=298, 300, 299, 306 -0.01  (0.39) 0.00  (0.36) 0.01  (0.39) 0.00  (0.40)
Peeling, Week 8, n=297, 296, 294, 293 -0.01  (0.41) -0.01  (0.42) -0.01  (0.40) 0.00  (0.43)
Peeling, Week 12, n=297, 296, 296, 294 -0.08  (0.44) -0.06  (0.40) -0.02  (0.50) -0.04  (0.43)
12.Secondary Outcome
Title Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging
Hide Description Itching and burning/stinging (piercing pain) were evaluated independently by the investigator as: 0 (none)=normal, no discomfort; 1 (slight)=noticeable discomfort that caused intermittent awareness; 2 (moderate)=noticeable discomfort that caused intermittent awareness and interfered occasionally with normal daily activities; 3 (strong)=definite continuous discomfort that interfered with normal daily activities. Change from Baseline was calculated as the value at Weeks 2, 4, 8, and 12 minus the value at Baseline.
Time Frame Baseline; Weeks 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants with data available at both Baseline and the indicated assessment week were analyzed.
Arm/Group Title Duac Low-dose (LD) Gel Clindamycin Gel BPO Gel Vehicle Gel
Hide Arm/Group Description:
Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Overall Number of Participants Analyzed 298 302 306 306
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Itching, Week 2, n=297, 301, 305, 305 -0.11  (0.67) -0.18  (0.67) -0.04  (0.64) -0.06  (0.65)
Itching, Week 4, n=298, 299, 299, 305 -0.11  (0.67) -0.18  (0.68) -0.07  (0.68) -0.10  (0.61)
Itching, Week 8, n=297, 295, 293, 291 -0.16  (0.75) -0.24  (0.69) -0.08  (0.68) -0.08  (0.62)
Itching, Week 12, n=297, 295, 294, 293 -0.21  (0.70) -0.28  (0.67) -0.13  (0.72) -0.13  (0.63)
Burning/Stinging, Week 2, n=297, 301, 305, 305 0.02  (0.58) -0.06  (0.48) -0.02  (0.56) -0.05  (0.53)
Burning/Stinging, Week 4, n=298, 2991, 299, 305 -0.06  (0.57) -0.09  (0.46) -0.05  (0.55) -0.02  (0.59)
Burning/Stinging, Week 8, n=297, 295, 293, 291 -0.05  (0.57) -0.09  (0.46) -0.05  (0.55) -0.06  (0.54)
Burning/Stinging, Week 12, n=297, 295, 294, 293 -0.09  (0.58) -0.13  (0.48) -0.04  (0.60) -0.04  (0.49)
13.Secondary Outcome
Title Mean Duration of Study Product Use
Hide Description Mean duration of study product use was calculated as the average total duration inclusive of missed applications of the study product.
Time Frame Baseline (Day 1) through Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Duac Low-dose (LD) Gel Clindamycin Gel BPO Gel Vehicle Gel
Hide Arm/Group Description:
Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Overall Number of Participants Analyzed 327 328 328 332
Mean (Standard Deviation)
Unit of Measure: days
79.5  (16.4) 78.0  (17.9) 78.0  (18.4) 77.8  (18.4)
14.Secondary Outcome
Title Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation
Hide Description An AE included, but was not limited to, any clinically significant worsening of a pre-existing condition; an event occurring from overdose (i.e., a dose higher than that indicated in the protocol) of the study product, whether accidental or intentional; an event occurring from abuse (e.g., use for nonstudy reasons) of the study product; or an event that was associated with the discontinuation of the use of the study product.
Time Frame Baseline (Day 1) through Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Duac Low-dose (LD) Gel Clindamycin Gel BPO Gel Vehicle Gel
Hide Arm/Group Description:
Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Overall Number of Participants Analyzed 327 328 328 332
Measure Type: Number
Unit of Measure: participants
Application Site Dermatitis 1 0 0 0
Application Site Hypersensitivity 0 0 1 0
Application Site Pruritus 0 0 1 1
Varicella 0 0 0 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Duac Low-dose (LD) Gel Clindamycin Gel BPO Gel Vehicle Gel
Hide Arm/Group Description Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
All-Cause Mortality
Duac Low-dose (LD) Gel Clindamycin Gel BPO Gel Vehicle Gel
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Duac Low-dose (LD) Gel Clindamycin Gel BPO Gel Vehicle Gel
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/327 (0.00%)   0/328 (0.00%)   1/328 (0.30%)   0/332 (0.00%) 
Psychiatric disorders         
Depression † 1  0/327 (0.00%)  0/328 (0.00%)  1/328 (0.30%)  0/332 (0.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Duac Low-dose (LD) Gel Clindamycin Gel BPO Gel Vehicle Gel
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   72/327 (22.02%)   83/328 (25.30%)   102/328 (31.10%)   87/332 (26.20%) 
Blood and lymphatic system disorders         
Iron Deficiency Anemia † 1  1/327 (0.31%)  0/328 (0.00%)  0/328 (0.00%)  0/332 (0.00%) 
Lymphadenopathy † 1  0/327 (0.00%)  1/328 (0.30%)  0/328 (0.00%)  1/332 (0.30%) 
Ear and labyrinth disorders         
Ear Congestion † 1  1/327 (0.31%)  0/328 (0.00%)  0/328 (0.00%)  0/332 (0.00%) 
Ear Pain † 1  0/327 (0.00%)  0/328 (0.00%)  0/328 (0.00%)  1/332 (0.30%) 
Eye disorders         
Blepharospasm † 1  0/327 (0.00%)  0/328 (0.00%)  0/328 (0.00%)  1/332 (0.30%) 
Conjunctivitis † 1  1/327 (0.31%)  0/328 (0.00%)  0/328 (0.00%)  0/332 (0.00%) 
Keratoconus † 1  0/327 (0.00%)  0/328 (0.00%)  0/328 (0.00%)  1/332 (0.30%) 
Gastrointestinal disorders         
Abdominal Discomfort † 1  0/327 (0.00%)  0/328 (0.00%)  0/328 (0.00%)  1/332 (0.30%) 
Abdominal Hernia † 1  0/327 (0.00%)  0/328 (0.00%)  0/328 (0.00%)  1/332 (0.30%) 
Abdominal Pain Upper † 1  1/327 (0.31%)  2/328 (0.61%)  1/328 (0.30%)  1/332 (0.30%) 
Cheilitis † 1  0/327 (0.00%)  0/328 (0.00%)  0/328 (0.00%)  1/332 (0.30%) 
Dental Caries † 1  1/327 (0.31%)  0/328 (0.00%)  0/328 (0.00%)  1/332 (0.30%) 
Diarrhea † 1  0/327 (0.00%)  2/328 (0.61%)  0/328 (0.00%)  0/332 (0.00%) 
Dyspepsia † 1  1/327 (0.31%)  0/328 (0.00%)  0/328 (0.00%)  1/332 (0.30%) 
Gastritis † 1  1/327 (0.31%)  0/328 (0.00%)  1/328 (0.30%)  0/332 (0.00%) 
Gastroesophageal Reflux Disease † 1  0/327 (0.00%)  0/328 (0.00%)  0/328 (0.00%)  1/332 (0.30%) 
Hiatus Hernia † 1  0/327 (0.00%)  0/328 (0.00%)  0/328 (0.00%)  1/332 (0.30%) 
Nausea † 1  0/327 (0.00%)  2/328 (0.61%)  0/328 (0.00%)  0/332 (0.00%) 
Stomach Discomfort † 1  2/327 (0.61%)  0/328 (0.00%)  0/328 (0.00%)  0/332 (0.00%) 
Toothache † 1  1/327 (0.31%)  1/328 (0.30%)  1/328 (0.30%)  1/332 (0.30%) 
Vomiting † 1  0/327 (0.00%)  1/328 (0.30%)  0/328 (0.00%)  1/332 (0.30%) 
Gastrointestinal Infection † 1  1/327 (0.31%)  1/328 (0.30%)  2/328 (0.61%)  0/332 (0.00%) 
General disorders         
Application Site Dermatitis † 1  2/327 (0.61%)  0/328 (0.00%)  0/328 (0.00%)  0/332 (0.00%) 
Application Site Dryness † 1  0/327 (0.00%)  0/328 (0.00%)  1/328 (0.30%)  1/332 (0.30%) 
Application Site Eczema † 1  0/327 (0.00%)  0/328 (0.00%)  1/328 (0.30%)  0/332 (0.00%) 
Application Site Erythema † 1  0/327 (0.00%)  0/328 (0.00%)  1/328 (0.30%)  0/332 (0.00%) 
Application Site Hypersensitivity † 1  0/327 (0.00%)  0/328 (0.00%)  1/328 (0.30%)  0/332 (0.00%) 
Application Site Irritation † 1  1/327 (0.31%)  0/328 (0.00%)  2/328 (0.61%)  0/332 (0.00%) 
Application Site Pain † 1  0/327 (0.00%)  1/328 (0.30%)  0/328 (0.00%)  0/332 (0.00%) 
Application Site Photosensitivity Reaction † 1  2/327 (0.61%)  1/328 (0.30%)  1/328 (0.30%)  2/332 (0.60%) 
Application Site Pruritus † 1  0/327 (0.00%)  1/328 (0.30%)  1/328 (0.30%)  1/332 (0.30%) 
Application Site Rash † 1  0/327 (0.00%)  0/328 (0.00%)  1/328 (0.30%)  0/332 (0.00%) 
Drug Intolerance † 1  0/327 (0.00%)  0/328 (0.00%)  1/328 (0.30%)  0/332 (0.00%) 
Influenza Like Illness † 1  0/327 (0.00%)  1/328 (0.30%)  0/328 (0.00%)  1/332 (0.30%) 
Mass † 1  1/327 (0.31%)  0/328 (0.00%)  0/328 (0.00%)  0/332 (0.00%) 
Pyrexia † 1  1/327 (0.31%)  1/328 (0.30%)  0/328 (0.00%)  2/332 (0.60%) 
Hepatobiliary disorders         
Hepatic Cyst † 1  0/327 (0.00%)  0/328 (0.00%)  0/328 (0.00%)  1/332 (0.30%) 
Immune system disorders         
Seasonal Allergy † 1  0/327 (0.00%)  0/328 (0.00%)  2/328 (0.61%)  0/332 (0.00%) 
Infections and infestations         
Acarodermatitis † 1  0/327 (0.00%)  0/328 (0.00%)  0/328 (0.00%)  1/332 (0.30%) 
Alveolar Osteitis † 1  1/327 (0.31%)  0/328 (0.00%)  0/328 (0.00%)  0/332 (0.00%) 
Arthritis Infective † 1  0/327 (0.00%)  1/328 (0.30%)  0/328 (0.00%)  0/332 (0.00%) 
Body Tinea † 1  0/327 (0.00%)  0/328 (0.00%)  0/328 (0.00%)  1/332 (0.30%) 
Bronchitis † 1  0/327 (0.00%)  2/328 (0.61%)  1/328 (0.30%)  1/332 (0.30%) 
Cellulitis † 1  0/327 (0.00%)  1/328 (0.30%)  0/328 (0.00%)  0/332 (0.00%) 
Conjunctivitis Infective † 1  0/327 (0.00%)  0/328 (0.00%)  0/328 (0.00%)  1/332 (0.30%) 
Ear Infection † 1  1/327 (0.31%)  0/328 (0.00%)  2/328 (0.61%)  0/332 (0.00%) 
Folliculitis † 1  1/327 (0.31%)  0/328 (0.00%)  0/328 (0.00%)  0/332 (0.00%) 
Fungal Infection † 1  0/327 (0.00%)  0/328 (0.00%)  1/328 (0.30%)  0/332 (0.00%) 
Furuncle † 1  0/327 (0.00%)  0/328 (0.00%)  1/328 (0.30%)  0/332 (0.00%) 
Gastroenteritis † 1  1/327 (0.31%)  0/328 (0.00%)  0/328 (0.00%)  1/332 (0.30%) 
Gastroenteritis Viral † 1  0/327 (0.00%)  0/328 (0.00%)  1/328 (0.30%)  2/332 (0.60%) 
Gingival Infection † 1  0/327 (0.00%)  1/328 (0.30%)  0/328 (0.00%)  1/332 (0.30%) 
Herpes Zoster † 1  1/327 (0.31%)  0/328 (0.00%)  0/328 (0.00%)  0/332 (0.00%) 
Impetigo † 1  0/327 (0.00%)  1/328 (0.30%)  0/328 (0.00%)  0/332 (0.00%) 
Infectious Mononucleosis † 1  0/327 (0.00%)  0/328 (0.00%)  0/328 (0.00%)  1/332 (0.30%) 
Influenza † 1  3/327 (0.92%)  5/328 (1.52%)  1/328 (0.30%)  4/332 (1.20%) 
Laryngitis † 1  0/327 (0.00%)  0/328 (0.00%)  1/328 (0.30%)  0/332 (0.00%) 
Lower Respiratory Tract Infection † 1  0/327 (0.00%)  0/328 (0.00%)  1/328 (0.30%)  0/332 (0.00%) 
Nasopharyngitis † 1  27/327 (8.26%)  23/328 (7.01%)  32/328 (9.76%)  19/332 (5.72%) 
Oral Candidiasis † 1  1/327 (0.31%)  0/328 (0.00%)  0/328 (0.00%)  0/332 (0.00%) 
Otitis Externa † 1  1/327 (0.31%)  0/328 (0.00%)  1/328 (0.30%)  0/332 (0.00%) 
Pharyngitis † 1  0/327 (0.00%)  1/328 (0.30%)  2/328 (0.61%)  0/332 (0.00%) 
Pharyngitis Streptococcal † 1  0/327 (0.00%)  1/328 (0.30%)  0/328 (0.00%)  2/332 (0.60%) 
Pneumonia † 1  0/327 (0.00%)  0/328 (0.00%)  0/328 (0.00%)  1/332 (0.30%) 
Respiratory Tract Infection † 1  0/327 (0.00%)  0/328 (0.00%)  0/328 (0.00%)  1/332 (0.30%) 
Rhinitis † 1  0/327 (0.00%)  2/328 (0.61%)  0/328 (0.00%)  1/332 (0.30%) 
Sinusitis † 1  2/327 (0.61%)  2/328 (0.61%)  2/328 (0.61%)  2/332 (0.60%) 
Staphylococcal Infection † 1  1/327 (0.31%)  0/328 (0.00%)  0/328 (0.00%)  0/332 (0.00%) 
Tinea Infection † 1  0/327 (0.00%)  0/328 (0.00%)  0/328 (0.00%)  1/332 (0.30%) 
Tonsillitis † 1  0/327 (0.00%)  0/328 (0.00%)  0/328 (0.00%)  1/332 (0.30%) 
Tooth Abscess † 1  1/327 (0.31%)  0/328 (0.00%)  0/328 (0.00%)  1/332 (0.30%) 
Tooth Infection † 1  1/327 (0.31%)  0/328 (0.00%)  1/328 (0.30%)  0/332 (0.00%) 
Upper Respiratory Tract Infection † 1  11/327 (3.36%)  13/328 (3.96%)  13/328 (3.96%)  13/332 (3.92%) 
Urinary Tract Infection † 1  1/327 (0.31%)  2/328 (0.61%)  1/328 (0.30%)  2/332 (0.60%) 
Vaginal Infection † 1  0/327 (0.00%)  1/328 (0.30%)  0/328 (0.00%)  1/332 (0.30%) 
Varicella † 1  0/327 (0.00%)  0/328 (0.00%)  0/328 (0.00%)  1/332 (0.30%) 
Viral Infection † 1  1/327 (0.31%)  0/328 (0.00%)  0/328 (0.00%)  1/332 (0.30%) 
Viral Upper Respiratory Tract Infection † 1  0/327 (0.00%)  0/328 (0.00%)  0/328 (0.00%)  1/332 (0.30%) 
Vulvovaginal Mycotic Infection † 1  0/327 (0.00%)  1/328 (0.30%)  0/328 (0.00%)  0/332 (0.00%) 
Injury, poisoning and procedural complications         
Arthropod Bite † 1  0/327 (0.00%)  0/328 (0.00%)  0/328 (0.00%)  0/332 (0.00%) 
Excoriation † 1  1/327 (0.31%)  1/328 (0.30%)  2/328 (0.61%)  1/332 (0.30%) 
Fractured Coccyx † 1  0/327 (0.00%)  1/328 (0.30%)  0/328 (0.00%)  0/332 (0.00%) 
Head Injury † 1  0/327 (0.00%)  1/328 (0.30%)  0/328 (0.00%)  0/332 (0.00%) 
Injury † 1  0/327 (0.00%)  0/328 (0.00%)  0/328 (0.00%)  0/332 (0.00%) 
Joint Sprain † 1  0/327 (0.00%)  2/328 (0.61%)  5/328 (1.52%)  0/332 (0.00%) 
Limb Crushing Injury † 1  1/327 (0.31%)  0/328 (0.00%)  0/328 (0.00%)  0/332 (0.00%) 
Muscle Strain † 1  0/327 (0.00%)  1/328 (0.30%)  0/328 (0.00%)  1/332 (0.30%) 
Neck Injury † 1  0/327 (0.00%)  0/328 (0.00%)  1/328 (0.30%)  0/332 (0.00%) 
Post-Traumatic Pain † 1  1/327 (0.31%)  0/328 (0.00%)  0/328 (0.00%)  0/332 (0.00%) 
Procedural Pain † 1  2/327 (0.61%)  1/328 (0.30%)  0/328 (0.00%)  2/332 (0.60%) 
Radius Fracture † 1  1/327 (0.31%)  0/328 (0.00%)  0/328 (0.00%)  0/332 (0.00%) 
Skin Laceration † 1  0/327 (0.00%)  2/328 (0.61%)  1/328 (0.30%)  1/332 (0.30%) 
Sunburn † 1  2/327 (0.61%)  5/328 (1.52%)  1/328 (0.30%)  2/332 (0.60%) 
Thermal Burn † 1  1/327 (0.31%)  0/328 (0.00%)  0/328 (0.00%)  0/332 (0.00%) 
Upper Limb Fracture † 1  0/327 (0.00%)  0/328 (0.00%)  2/328 (0.61%)  0/332 (0.00%) 
Wrist Fracture † 1  0/327 (0.00%)  0/328 (0.00%)  1/328 (0.30%)  0/332 (0.00%) 
Investigations         
Blood Testosterone Increased † 1  0/327 (0.00%)  0/328 (0.00%)  1/328 (0.30%)  0/332 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia † 1  1/327 (0.31%)  0/328 (0.00%)  0/328 (0.00%)  0/332 (0.00%) 
Back Pain † 1  2/327 (0.61%)  1/328 (0.30%)  0/328 (0.00%)  0/332 (0.00%) 
Musculoskeletal Stiffness † 1  0/327 (0.00%)  0/328 (0.00%)  1/328 (0.30%)  0/332 (0.00%) 
Neck Pain † 1  1/327 (0.31%)  0/328 (0.00%)  0/328 (0.00%)  0/332 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Melanocytic Naevus † 1  0/327 (0.00%)  1/328 (0.30%)  0/328 (0.00%)  0/332 (0.00%) 
Skin Papilloma † 1  1/327 (0.31%)  0/328 (0.00%)  1/328 (0.30%)  0/332 (0.00%) 
Nervous system disorders         
Convulsion † 1  0/327 (0.00%)  0/328 (0.00%)  0/328 (0.00%)  1/332 (0.30%) 
Dizziness † 1  0/327 (0.00%)  1/328 (0.30%)  0/328 (0.00%)  0/332 (0.00%) 
Headache † 1  4/327 (1.22%)  8/328 (2.44%)  9/328 (2.74%)  7/332 (2.11%) 
Migraine † 1  1/327 (0.31%)  0/328 (0.00%)  0/328 (0.00%)  0/332 (0.00%) 
Paraesthesia † 1  0/327 (0.00%)  0/328 (0.00%)  1/328 (0.30%)  0/332 (0.00%) 
Sinus Headache † 1  0/327 (0.00%)  1/328 (0.30%)  0/328 (0.00%)  0/332 (0.00%) 
Syncope † 1  0/327 (0.00%)  0/328 (0.00%)  1/328 (0.30%)  0/332 (0.00%) 
Tremor † 1  0/327 (0.00%)  0/328 (0.00%)  0/328 (0.00%)  1/332 (0.30%) 
Psychiatric disorders         
Anxiety † 1  0/327 (0.00%)  0/328 (0.00%)  1/328 (0.30%)  0/332 (0.00%) 
Attention Deficit/Hyperactivity Disorder † 1  0/327 (0.00%)  0/328 (0.00%)  0/328 (0.00%)  1/332 (0.30%) 
Depression † 1  1/327 (0.31%)  0/328 (0.00%)  1/328 (0.30%)  0/332 (0.00%) 
Nephrolithiasis † 1  0/327 (0.00%)  0/328 (0.00%)  1/328 (0.30%)  0/332 (0.00%) 
Renal and urinary disorders         
Nephrolithiasis † 1  0/327 (0.00%)  1/328 (0.30%)  0/328 (0.00%)  0/332 (0.00%) 
Reproductive system and breast disorders         
Adnexa Uteri Pain † 1  0/327 (0.00%)  0/328 (0.00%)  0/328 (0.00%)  1/332 (0.30%) 
Breast Cyst † 1  0/327 (0.00%)  1/328 (0.30%)  0/328 (0.00%)  0/332 (0.00%) 
Dysmenorrhoea † 1  1/327 (0.31%)  0/328 (0.00%)  1/328 (0.30%)  2/332 (0.60%) 
Endometriosis † 1  0/327 (0.00%)  1/328 (0.30%)  0/328 (0.00%)  0/332 (0.00%) 
Ovarian Cyst Ruptured † 1  0/327 (0.00%)  0/328 (0.00%)  1/328 (0.30%)  0/332 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough † 1  2/327 (0.61%)  0/328 (0.00%)  1/328 (0.30%)  2/332 (0.60%) 
Epistaxis † 1  0/327 (0.00%)  1/328 (0.30%)  0/328 (0.00%)  0/332 (0.00%) 
Nasal Congestion † 1  1/327 (0.31%)  1/328 (0.30%)  2/328 (0.61%)  0/332 (0.00%) 
Pharyngolaryngeal Pain † 1  3/327 (0.92%)  0/328 (0.00%)  2/328 (0.61%)  2/332 (0.60%) 
Respiratory Tract Congestion † 1  0/327 (0.00%)  0/328 (0.00%)  1/328 (0.30%)  0/332 (0.00%) 
Rhinitis Allergic † 1  0/327 (0.00%)  0/328 (0.00%)  0/328 (0.00%)  1/332 (0.30%) 
Rhinorrhea † 1  0/327 (0.00%)  0/328 (0.00%)  0/328 (0.00%)  1/332 (0.30%) 
Sinus Congestion † 1  1/327 (0.31%)  0/328 (0.00%)  1/328 (0.30%)  1/332 (0.30%) 
Skin and subcutaneous tissue disorders         
Acne † 1  0/327 (0.00%)  1/328 (0.30%)  1/328 (0.30%)  1/332 (0.30%) 
Chloasma † 1  0/327 (0.00%)  0/328 (0.00%)  1/328 (0.30%)  0/332 (0.00%) 
Dermatitis Atopic † 1  0/327 (0.00%)  1/328 (0.30%)  0/328 (0.00%)  0/332 (0.00%) 
Dermatitis Contact † 1  1/327 (0.31%)  1/328 (0.30%)  0/328 (0.00%)  1/332 (0.30%) 
Ingrowing Nail † 1  0/327 (0.00%)  0/328 (0.00%)  0/328 (0.00%)  1/332 (0.30%) 
Pruritus † 1  0/327 (0.00%)  0/328 (0.00%)  1/328 (0.30%)  1/332 (0.30%) 
Rash † 1  0/327 (0.00%)  1/328 (0.30%)  0/328 (0.00%)  0/332 (0.00%) 
Urticaria † 1  0/327 (0.00%)  0/328 (0.00%)  2/328 (0.61%)  0/332 (0.00%) 
Surgical and medical procedures         
Elective Surgery † 1  0/327 (0.00%)  0/328 (0.00%)  1/328 (0.30%)  0/332 (0.00%) 
Mole Excision † 1  1/327 (0.31%)  0/328 (0.00%)  0/328 (0.00%)  0/332 (0.00%) 
Tooth Extraction † 1  0/327 (0.00%)  0/328 (0.00%)  0/328 (0.00%)  1/332 (0.30%) 
Wisdom Teeth Removal † 1  1/327 (0.31%)  0/328 (0.00%)  2/328 (0.61%)  2/332 (0.60%) 
Vascular disorders         
Hypertension † 1  0/327 (0.00%)  0/328 (0.00%)  1/328 (0.30%)  0/332 (0.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
[Not Specified]
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
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Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Publications:
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Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT00776919    
Other Study ID Numbers: 114677
First Submitted: October 21, 2008
First Posted: October 22, 2008
Results First Submitted: December 21, 2011
Results First Posted: January 30, 2012
Last Update Posted: November 23, 2016