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| Sponsor: | Stiefel, a GSK Company |
|---|---|
| Information provided by: | Stiefel, a GSK Company |
| ClinicalTrials.gov Identifier: | NCT00689117 |
Purpose
The purpose of this study is to demonstrate the safety and effectiveness of W0265 gel in subjects with acne vulgaris. The hypothesis is that W0265 is superior to Clindamycin Gel, Tretinoin Gel and Vehicle Gel for the treatment of acne vulgaris.
| Condition | Intervention | Phase |
|---|---|---|
|
Acne Vulgaris Acne |
Drug: W0265 Gel Drug: Clindamycin Gel (clindamycin ) Drug: Tretinoin Gel (tretinoin) Drug: Vehicle Gel |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase 3 Multicenter, Randomized, Double-Blind, Active And Vehicle-Controlled Study Of The Safety And Efficacy Of W0265 in Subjects With Acne Vulgaris |
| Enrollment: | 1656 |
| Study Start Date: | April 2008 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
W0265 Gel
|
Drug: W0265 Gel
Once daily in the evening for 12 weeks
|
|
2: Active Comparator
Clindamycin Gel (clindamycin)
|
Drug: Clindamycin Gel (clindamycin )
once daily in the evening for 12 weeks
|
|
3: Active Comparator
Tretinoin Gel (tretinoin)
|
Drug: Tretinoin Gel (tretinoin)
Once daily in the evening for 12 weeks
|
|
4: Placebo Comparator
Vehicle Gel
|
Drug: Vehicle Gel
Once daily in the evening for 12 weeks
|
W0265 gel is a fixed-combination product that addresses the multifactorial factors of acne vulgaris pathogenesis. Based on numerous nonclinical pharmacology studies of each active ingredient, it is expected that this new product will have three biological actions: 1) comedolytic, 2) antimicrobial, and 3) anti-inflammatory.
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Radiant Research | |
| Birmingham, Alabama, United States, 35209 | |
| Coastal Clinical Research, Inc. | |
| Mobile, Alabama, United States, 33608 | |
| United States, Arkansas | |
| Burke Pharmaceutical Research | |
| Hot Springs, Arkansas, United States, 71913 | |
| United States, California | |
| University Clinical Trials | |
| San Diego, California, United States, 92103 | |
| Center for Dermatology, Cosmetic and Laser Surgery | |
| Fremont, California, United States, 94538 | |
| United States, Colorado | |
| Longmont Medical Research Network | |
| Longmont, Colorado, United States, 80501 | |
| United States, Florida | |
| FXM Research Corporation | |
| Miami, Florida, United States, 33175 | |
| Advanced Dermatolgy & Cosemtic Surgery | |
| Ormond Beach, Florida, United States, 32174 | |
| FXM Research - Miramar | |
| Miramar, Florida, United States, 33027 | |
| United States, Kentucky | |
| Dermatology Specialists | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Massachusetts | |
| Massachusettes General Hospital - Clinical Unit for Research Trials in Skin | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Michigan | |
| University of Michigan | |
| Ann Arbor, Michigan, United States, 48109 | |
| Henry Ford Medical Center | |
| Detroit, Michigan, United States, 48202 | |
| United States, Minnesota | |
| Minnesota Clinical Study Center | |
| Fridley, Minnesota, United States, 55432 | |
| United States, Nebraska | |
| Skin Specialists, P.C. | |
| Omaha, Nebraska, United States, 68144 | |
| United States, New Mexico | |
| Academic Dermatology Research | |
| Albuquerque, New Mexico, United States, 87106 | |
| United States, Ohio | |
| Dermatology Research Associates, Inc. | |
| Cincinnati, Ohio, United States, 45230 | |
| United States, Pennsylvania | |
| Yardley Dermatology Associates | |
| Yardley, Pennsylvania, United States, 19067 | |
| United States, Rhode Island | |
| Clinical Partners, LLC | |
| Johnston, Rhode Island, United States, 02919 | |
| United States, Tennessee | |
| Tennessee Clinical Research | |
| Nashville, Tennessee, United States, 37215 | |
| Dermatology Associates of Knoxville, P.C. | |
| Knoxville, Tennessee, United States, 37934 | |
| United States, Texas | |
| DermResearch, Inc. | |
| Austin, Texas, United States, 78759 | |
| J & S Studies, Inc. | |
| College Station, Texas, United States, 77840 | |
| The Hair and Skin Research Treatment Center | |
| Dallas, Texas, United States, 75246 | |
| United States, Utah | |
| Dermatology Research Center, Inc. | |
| Salt Lake City, Utah, United States, 84124 | |
| United States, Washington | |
| Premier Clincial Research | |
| Spokane, Washington, United States, 99204 | |
| United States, Wisconsin | |
| Advanced Healthcare | |
| Milwaukee, Wisconsin, United States, 53209 | |
| Belize | |
| Dermatology And Skin Centre | |
| Belize City, Belize | |
| Dr. Moguel's Clinic | |
| Belize City, Belize | |
| Canada, Ontario | |
| K. Papp Clinical Research, Inc. | |
| Waterloo, Ontario, Canada, N2J 1C4 | |
| Windsor Clinical Research Center, Inc. | |
| Windsor, Ontario, Canada, N8W 5L7 | |
| Canada, Quebec | |
| Innovaderm Research, Inc. | |
| Montreal, Quebec, Canada, H2K 4L5 | |
| Study Director: | David A. Angulo, MD | Stiefel Labortories, Inc. |
More Information
| Responsible Party: | Stiefel Laboratories, Inc. ( Jason Mann, Director, Global Clinical Operations ) |
| Study ID Numbers: | W0265-03 |
| Study First Received: | May 24, 2008 |
| Last Updated: | June 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00689117 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
|
Acne Vulgaris Acne |
|
Anti-Infective Agents Clindamycin Facial Dermatoses Skin Diseases Clindamycin-2-phosphate Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors Sebaceous Gland Diseases |
Acne Vulgaris Pharmacologic Actions Keratolytic Agents Protein Synthesis Inhibitors Anti-Bacterial Agents Acneiform Eruptions Therapeutic Uses Tretinoin Dermatologic Agents |