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Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With Acne

This study has been completed.
Sponsor:
Collaborators:
Rho, Inc.
Quintiles, Inc.
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier:
NCT00776919
First received: October 21, 2008
Last updated: October 11, 2016
Last verified: October 2016
Results First Received: December 21, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Acne Vulgaris
Interventions: Drug: clindamycin / benzoyl peroxide gel
Drug: clindamycin gel
Drug: BPO gel
Drug: vehicle gel

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Duac Low-dose (LD) Gel 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 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
BPO Gel 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
Vehicle Gel 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

Participant Flow:   Overall Study
    Duac Low-dose (LD) Gel   Clindamycin Gel   BPO Gel   Vehicle Gel
STARTED   327   328   328   332 
COMPLETED   300   295   296   293 
NOT COMPLETED   27   33   32   39 
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 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Duac Low-dose (LD) Gel 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 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
BPO Gel 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
Vehicle Gel 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 Total of all reporting groups

Baseline Measures
   Duac Low-dose (LD) Gel   Clindamycin Gel   BPO Gel   Vehicle Gel   Total 
Overall Participants Analyzed 
[Units: Participants]
 327   328   328   332   1315 
Age 
[Units: Years]
Mean (Standard Deviation)
 20.0  (7.0)   20.2  (6.9)   20.6  (7.1)   20.7  (7.4)   20.4  (7.1) 
Gender 
[Units: Participants]
         
Female   202   180   203   210   795 
Male   125   148   125   122   520 
Race/Ethnicity, Customized 
[Units: 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 


  Outcome Measures
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1.  Primary:   Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12   [ Time Frame: Baseline (Day 1) and Week 12 ]

2.  Primary:   Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts   [ Time Frame: Baseline (Day 1) and Week 12 ]

3.  Primary:   Mean Change From Baseline to Week 12 in Non-inflammatory Lesion Counts   [ Time Frame: Baseline (Day 1) and Week 12 ]

4.  Primary:   Mean Change From Baseline to Week 12 in Total Lesion Counts   [ Time Frame: Baseline (Day 1) and Week 12 ]

5.  Secondary:   Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory)   [ Time Frame: Baseline (Day 1) and Week 12 ]

6.  Secondary:   Number of Participants Who Had a Subject Global Assessment (SGA) Score of 0 or 1 at Week 12   [ Time Frame: Week 12 ]

7.  Secondary:   Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12   [ Time Frame: Week 12 ]

8.  Secondary:   Mean Change From Baseline to Week 12 in Systolic and Diastolic Blood Pressure   [ Time Frame: Baseline (Day 1) and Week 12 ]

9.  Secondary:   Mean Change From Baseline to Week 12 in Temperature   [ Time Frame: Baseline (Day 1) and Week 12 ]

10.  Secondary:   Mean Change From Baseline to Week 12 in Pulse Rate   [ Time Frame: Baseline (Day 1) and Week 12 ]

11.  Secondary:   Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling   [ Time Frame: Baseline; Weeks 2, 4, 8, and 12 ]
  Hide Outcome Measure 11

Measure Type Secondary
Measure Title Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT Population. Only those participants with data available at both Baseline and the indicated assessment week were analyzed.

Reporting Groups
  Description
Duac Low-dose (LD) Gel 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 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
BPO Gel 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
Vehicle Gel 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

Measured Values
   Duac Low-dose (LD) Gel   Clindamycin Gel   BPO Gel   Vehicle Gel 
Participants Analyzed 
[Units: Participants]
 298   302   306   306 
Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling 
[Units: Scores on a scale]
Mean (Standard Deviation)
       
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) 

No statistical analysis provided for Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling



12.  Secondary:   Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging   [ Time Frame: Baseline; Weeks 2, 4, 8, and 12 ]

13.  Secondary:   Mean Duration of Study Product Use   [ Time Frame: Baseline (Day 1) through Week 12 ]

14.  Secondary:   Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation   [ Time Frame: Baseline (Day 1) through Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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