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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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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

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 ]

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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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00776919     History of Changes
Other Study ID Numbers: 114677, W0261-301
Study First Received: October 21, 2008
Results First Received: December 21, 2011
Last Updated: February 9, 2012
Health Authority: Canada: Health Canada
United States: Food and Drug Administration