Acne Vulgaris Clinical Trial
| Verified date | April 2008 |
| Source | Dow Pharmaceutical Sciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to assess the effectiveness of IDP-110 in treating patients with acne vulgaris.
| Status | Completed |
| Enrollment | 1399 |
| Est. completion date | |
| Est. primary completion date | August 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 12 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - Presence of inflammatory and non-inflammatory lesions Exclusion Criteria: - Dermatological conditions of the face other than acne that could interfere with clinical evaluations - Female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Derm Center of Augusta | Augusta | Georgia |
| United States | DermResearch, Inc. | Austin | Texas |
| United States | Skin Care Research, Inc. | Boca Raton | Florida |
| United States | Atlantic Dermatologic Associates, LLP | Brooklyn | New York |
| United States | SUNY Downstate Medical Center | Brooklyn | New York |
| United States | J & S Studies, Inc. | Bryan | Texas |
| United States | Thomas J. Stephens & Associates | Carrollton | Texas |
| United States | Advanced Dermatology and Cosmetic Surgery | Clermont | Florida |
| United States | Michigan Center for Research Corp. | Clinton Township | Michigan |
| United States | Dallas Associated Dermatologists | Dallas | Texas |
| United States | Hudson Dermatology | Evansville | Indiana |
| United States | Minnesota Clinical Study Center | Fridley | Minnesota |
| United States | Milton S. Hershey Medical Center | Hershey | Pennsylvania |
| United States | Webster Dermatology, PA | Hockessin | Delaware |
| United States | Burke Pharmaceutical Research | Hot Springs | Arkansas |
| United States | North Florida Dermatology Associates, PA | Jacksonville | Florida |
| United States | Dermatology Specialists Research | Louisville | Kentucky |
| United States | Education & Research Foundation | Lynchburg | Virginia |
| United States | Madison Skin & Research, Inc. | Madison | Wisconsin |
| United States | DuPage Medical Group | Naperville | Illinois |
| United States | The Savin Center, PC | New Haven | Connecticut |
| United States | Office of Fran E. Cook-Bolden, MD | New York | New York |
| United States | MedaPhase Inc. | Newnan | Georgia |
| United States | Virginia Clinical Research, Inc | Norfolk | Virginia |
| United States | Central Sooner Research | Norman | Oklahoma |
| United States | Advanced Dermatology and Cosmetic Surgery | Ormond Beach | Florida |
| United States | Dermatology Research | Pinellas Park | Florida |
| United States | Dermatology Associates of Rochester | Rochester | New York |
| United States | Helendale Dermatology and Medical Spa | Rochester | New York |
| United States | Gwinnett Clinical Research Center, Inc. | Snellville | Georgia |
| United States | South Bend Clinic | South Bend | Indiana |
| United States | DermResearch Center of New York | Stony Brook | New York |
| United States | Florida Dermatology Institute | West Palm Beach | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Dow Pharmaceutical Sciences |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline in number of lesions | 12 weeks | No | |
| Secondary | Change from baseline in global severity | 12 weeks | No |
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