Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With Acne
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ClinicalTrials.gov Identifier: NCT00776919 |
Recruitment Status :
Completed
First Posted : October 22, 2008
Results First Posted : January 30, 2012
Last Update Posted : November 23, 2016
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Sponsor:
Stiefel, a GSK Company
Collaborators:
Rho, Inc.
Quintiles, Inc.
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )
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Study Type | Interventional |
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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 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Duac Low-dose (LD) Gel | Clindamycin Gel | BPO Gel | Vehicle Gel |
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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 |
Baseline Characteristics
Arm/Group Title | Duac Low-dose (LD) Gel | Clindamycin Gel | BPO Gel | Vehicle Gel | Total | |
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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 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 327 participants | 328 participants | 328 participants | 332 participants | 1315 participants | |
Female |
202 61.8%
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180 54.9%
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203 61.9%
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210 63.3%
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795 60.5%
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Male |
125 38.2%
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148 45.1%
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125 38.1%
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122 36.7%
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520 39.5%
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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 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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
Name/Title: | GSK Response Center |
Organization: | GlaxoSmithKline |
Phone: | 866-435-7343 |
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 |