A Double-Blind, Placebo-Controlled, Pilot Study to Determine the Safety and Efficacy of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel For The Treatment of Rosacea Over 12 Weeks

Purpose:

The purpose of this study is to determine whether Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel are effective and safe in the treatment of papulopustular rosacea.

Criteria:

Inclusion Criteria: 1. Subjects 18 years of age and older. 2. Clinical diagnosis of papulopustular facial rosacea. 3. A minimum of 4 but not more than 50 facial inflammatory lesions (papules plus pustules). 4. Willing and able to understand and sign informed consent. 5. Able to complete study and comply with study procedures. Exclusion Criteria: 1. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring systemic treatment. 2. History or presence of regional enteritis or inflammatory bowel disease (e.g., ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of antibiotic-associated colitis, bloody diarrhea) or similar symptoms. 3. Use of topical rosacea treatments in the past 2 weeks. 4. Use of systemic antibiotics in the past 4 weeks. 5. Use of systemic retinoids within the past 3 months. 6. Use of laser or light based rosacea treatments within the past 2 months. 7. Concomitant use of medications that are reported to exacerbate rosacea, such as topical and systemic steroids as these may impact assessments. 8. Current drug or alcohol abuse. 9. Other dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, atopic dermatitis, perioral dermatitis or acne vulgaris. 10. Clinically significant abnormal findings or conditions (other than rosacea), which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study. 11. Subjects who are pregnant or planning a pregnancy. 12. Use of any investigational therapy within the past 4 weeks. 13. Known hypersensitivity or previous allergic reaction to clindamycin or retinoids

Study is Available At:

Original ID:

2008-P-001828

NCT ID:

NCT00823901

Secondary ID:

Study Acronym:

Brief Title:

Safety and Efficacy Study of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel to Treat Rosacea

Official Title:

A Double-Blind, Placebo-Controlled, Pilot Study to Determine the Safety and Efficacy of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel For The Treatment of Rosacea Over 12 Weeks

ClinicalTrials.gov Link:

http://clinicaltrials.gov/show/NCT00823901

Overall Status:

Recruiting

Study Phase:

Phase 2/Phase 3

Genders:

Both

Minimum Age:

18 Years

Maximum Age:

N/A

Study Source:

Massachusetts General Hospital

Oversight Authority:

United States: Food and Drug Administration

Reasons Why Stopped:

Study Type:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification:

Number of Arms:

2

Number of Groups:

0

Total Enrollment:

86

Enrollment Type:

Anticipated

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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