Severe Acne Vulgaris Clinical Trial
— ACCESS IOfficial title:
Efficacy and Safety Comparison of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Associated With Doxycycline Hyclate 100 mg Tablets Versus Adapalene 0.1% / Benzoyl Peroxide 2.5% Vehicle Gel Associated With Doxycycline Hyclate 100 mg Tablets in the Treatment of Severe Acne Vulgaris.
| Verified date | March 2010 |
| Source | Galderma R&D |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide (quoted as BPO) 2.5% Gel associated with Doxycycline Hyclate 100 mg Tablets compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Doxycycline Hyclate 100 mg Tablets, in the treatment of severe acne vulgaris. The safety of the two treatment regimens will also be evaluated.
| Status | Completed |
| Enrollment | 459 |
| Est. completion date | February 2009 |
| Est. primary completion date | February 2009 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years to 35 Years |
| Eligibility | Inclusion Criteria: - Male or female Subjects of any race, aged 12 to 35 years inclusive - Subjects with severe facial acne (global severity score of 4) - Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face, excluding the nose - Subjects with a minimum of 30 and a maximum of 120 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose Exclusion Criteria: - Subjects with more than 3 nodules or cysts on the face, - Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.) |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Galderma Investigational Site | Barrie | Ontario |
| Canada | Galderma Investigational Site | North Bay | Ontario |
| Canada | Galderma Investigational Site | Quebec city | Quebec |
| Canada | Galderma Investigational Site | Windsor | Ontario |
| Puerto Rico | Galderma Investigational Site | Aibonito | |
| Puerto Rico | Galderma Investigational Site | Carolina | |
| United States | Galderma Investigational Site | Albuquerque | New Mexico |
| United States | Galderma Investigational Site | Arlington | Texas |
| United States | Galderma Investigational Site | Austin | Texas |
| United States | Galderma Investigational Site | Chicago | Illinois |
| United States | Galderma Investigational Site | College Station | Texas |
| United States | Galderma Investigational Site | Denver | Colorado |
| United States | Galderma Investigational Site | Detroit | Michigan |
| United States | Galderma Investigational Site | Evansville | Indiana |
| United States | Galderma Investigational Site | Fort Gratiot | Michigan |
| United States | Galderma Investigational Site | Fridley | Minnesota |
| United States | Galderma Investigational Site | Hazleton | Pennsylvania |
| United States | Galderma Investigational Site | Hershey | Pennsylvania |
| United States | Galderma Investigational Site | Houston | Texas |
| United States | Galderma Investigational Site | Longmont | Colorado |
| United States | Galderma Investigational Site | Louisville | Kentucky |
| United States | Galderma Investigational Site | Lubbock | Texas |
| United States | Galderma Investigational Site | Miami | Florida |
| United States | Galderma Investigational Site | Oceanside | California |
| United States | Galderma Investigational Site | Omaha | Nebraska |
| United States | Galderma Investigational Site | Overland Park | Kansas |
| United States | Galderma Investigational Site | San Antonio | Texas |
| United States | Galderma Investigational Site | San Diego | California |
| United States | Galderma Investigational Site | Simpsonville | South Carolina |
| United States | Galderma Investigational Site | Snellville | Georgia |
| United States | Galderma Investigational Site | Stony Brook | New York |
| United States | Galderma Investigational Site | Warren | Ohio |
| United States | Galderma Investigational Site | Webster | Texas |
| United States | Galderma Investigational Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Galderma R&D |
United States, Canada, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percent Change From Baseline in Total Lesion Counts at Week 12. | Week 12 | ||
| Secondary | Percent Change From Baseline in Inflammatory Lesion Counts at Week 12. | Week 12 | ||
| Secondary | Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12 | Week 12 | ||
| Secondary | Success Rate on the Investigator's Global Assessment | Percentage of subjects graded "Clear" or "Almost Clear" on 6-point IGA scale(0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe and 5=very severe)at week 12 | Week 12 | |
| Secondary | Percent of Subjects With Adverse Events | Percent of subjects with Adverse Events all along the study (up to 12 weeks follow-up period) | Up to 12 weeks |