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NCT00713609 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study of Clindamycin/Benzoyl Peroxide/Tazarotene Cream in Subjects With Acne
A Phase 2 study of Acne Vulgaris, sponsored by Stiefel, a GSK Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 591
- Enrollment target
- 16
- Study locations
NCT00713609: Completed Phase 2 study of Acne Vulgaris, sponsored by Stiefel, a GSK Company.
NCT00713609 is a Phase 2 study of Acne Vulgaris that has completed, run by Stiefel, a GSK Company. The registered enrollment target is 591 participants, above the 267-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (121% higher). The trial reports 16 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00713609, a Phase 2 study of Acne Vulgaris, has completed, sponsored by Stiefel, a GSK Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 591 participants
- Enrollment target
- 16
- Study locations
Study Summary
Benzoyl peroxide, clindamycin and tazarotene are known to be effective treatment alternative for acne vulgaris. The purpose of this study is to assess the safety and efficacy of a combination product including these actives for the treatment of acne vulgaris. You may be suitable to take part in this study because you have acne vulgaris on your face. Acne vulgaris usually affects the face, but it can also affect the skin on the chest, arms, legs, and back.
Primary Outcome
The investigator or designee took count of inflammatory lesions (papules, pustules, nodules and cysts \[only post-Baseline\]) (ILC), noninflammatory lesions (open and closed comedones) (NILC) and total lesions (TLC) at Baseline, Weeks 2, 4, 8, and 12. Lesion counts were confined to the face. Each of 3 lesion counts (total, inflammatory and non-inflammatory) was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, center, Baseline value and treatment-by-center interac
Conditions Studied
Interventions
- DRUG Vehicle cream
- DRUG Vehicle gel
- DRUG Benzoyl peroxide gel
- DRUG Clindamycin gel
- DRUG Tazarotene cream
Study Locations (16)
Texas
- Dermatology Treatment & Research Center - Dallas
- Suzanne Bruce and Associates, PA - Houston
- Dermatology Clinical Research Center of San Antonio - San Antonio
California
- Center for Dermatology Cosmetic and Laser Surgery - Fremont
- Center for Dermatology and Laser Surgery - Sacramento
North Carolina
- University of North Carolina Chapel Hill - Chapel Hill
- Dermatology Consulting Services - High Point
Tennessee
- Rivergate Dermatology & Skin Care Center - Goodlettsville
- The Skin Wellness Center, PC - Knoxville
Arkansas
- Dermatology Research of Arkansas - Little Rock
Colorado
- Boulder Medical Center, P.C. - Boulder
Florida
- Dermatology Associates Research - Coral Gables
Georgia
- MedaPhase, Inc. - Newnan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 591 participants |
| Start Date | 2008-06 |
| Est. Completion | 2009-03 |
| Phase | Phase 2 |
What the finished NCT00713609 record still lists
NCT00713609 is an interventional study that assigns participants to a tested intervention. The registered 591 participants enrollment target is mid-sized for trials with a published cap, above the 267-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (121% higher).
The record links to 1 condition, with Acne Vulgaris appearing as the primary indexed condition, and to 5 interventions - of which Vehicle cream is the first listed.
NCT00713609 lists 16 locations in 11 states (Texas, California, North Carolina).
Frequently Asked Questions
What is clinical trial NCT00713609 about?
NCT00713609 is a clinical study titled "Safety and Efficacy Study of Clindamycin/Benzoyl Peroxide/Tazarotene Cream in Subjects With Acne". Benzoyl peroxide, clindamycin and tazarotene are known to be effective treatment alternative for acne vulgaris. The purpose of this study is to assess the safety and efficacy of a combination product including these actives for the treatment of acne vulgaris. You may be suitable to take part in thi...
What is the current status of trial NCT00713609?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 591 participants. The study started on 2008-06. Estimated completion is 2009-03.
What conditions does trial NCT00713609 study?
This clinical trial studies the following conditions: Acne Vulgaris.
What interventions are being tested in trial NCT00713609?
The interventions under investigation include: Vehicle cream (DRUG), Vehicle gel (DRUG), Benzoyl peroxide gel (DRUG), Clindamycin gel (DRUG), Tazarotene cream (DRUG).
Who is sponsoring clinical trial NCT00713609?
This trial is sponsored by Stiefel, a GSK Company, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00713609 being conducted?
This trial has 16 study locations across Arkansas, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acne Vulgaris
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00713609's enrollment target sits among peer trials
591 14th of 67 higher than 54 of 67 other Acne Vulgaris trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acne Vulgaris trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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