Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With Acne

This study has been completed.
Sponsor:
Collaborators:
RHO CRO
Quintiles CRO
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00776919
First received: October 21, 2008
Last updated: February 9, 2012
Last verified: February 2012
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.
No text entered.

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  
Number of Participants  
[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  
Number of 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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