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| Sponsor: | Stiefel, a GSK Company |
|---|---|
| Collaborators: |
RHO CRO Quintiles CRO GlaxoSmithKline |
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00776919 |
Purpose
This is a Randomized, Double-Blind, Controlled Study to evaluate the Safety and Efficacy of a clindamycin / benzoyl peroxide gel in Subjects with Acne Vulgaris
| Condition | Intervention | Phase |
|---|---|---|
|
Acne Vulgaris |
Drug: clindamycin / benzoyl peroxide gel Drug: clindamycin gel Drug: BPO gel Drug: vehicle gel |
Phase III |
| 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 |
| Official Title: | A Phase 3 Multicenter, Randomized, Double-Blind, Active And Vehicle-Controlled Study Of The Safety And Efficacy Of A Clindamycin / Benzoyl Peroxide Gel Versus Clindamycin Gel Versus Benzoyl Peroxide Gel Versus Vehicle Gel In Subjects With Acne Vulgaris |
| Enrollment: | 1315 |
| Study Start Date: | October 2008 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
clindamycin / benzoyl peroxide gel
|
Drug: clindamycin / benzoyl peroxide gel
Once a day application to the face
|
|
Active Comparator: 2
Clindamycin gel
|
Drug: clindamycin gel
Once a day application to the face
|
|
Active Comparator: 3
BPO gel
|
Drug: BPO gel
Once a day application to the face
|
|
Placebo Comparator: 4
vehicle gel
|
Drug: vehicle gel
Once a day application to the face
|
A multicenter, randomized, double-blind, comparator and vehicle-controlled study in subjects with acne vulgaris. Approximately 1320 subjects will be enrolled. Subjects will be randomized to 1 of 4 parallel study groups in a 1:1:1:1 ratio (clindamycin / benzoyl peroxide gel:clindamycin gel:BPO gel:vehicle gel).
Eligibility| Ages Eligible for Study: | 12 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 24 Study Locations| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| 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 |
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Acne Vulgaris Acne |
|
Acne Vulgaris Acneiform Eruptions Skin Diseases Facial Dermatoses Sebaceous Gland Diseases Benzoyl Peroxide Clindamycin Clindamycin-2-phosphate |
Dermatologic Agents Therapeutic Uses Pharmacologic Actions Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Bacterial Agents Anti-Infective Agents |