Status:
COMPLETED
Safety and Efficacy Study of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel to Treat Rosacea
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Medicis Pharmaceutical Corporation
Conditions:
Rosacea
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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.
Detailed Description
Currently, there is no known cure for rosacea. The most effective treatment is systemic antibiotics, particularly of the tetracycline family. Topical treatments include metronidazole, antibacterials s...
Eligibility Criteria
Inclusion
- Subjects 18 years of age and older.
- Clinical diagnosis of papulopustular facial rosacea.
- A minimum of 4 but not more than 50 facial inflammatory lesions (papules plus pustules).
- Willing and able to understand and sign informed consent.
- Able to complete study and comply with study procedures.
Exclusion
- Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring systemic treatment.
- 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.
- Use of topical rosacea treatments in the past 2 weeks.
- Use of systemic antibiotics in the past 4 weeks.
- Use of systemic retinoids within the past 3 months.
- Use of laser or light based rosacea treatments within the past 2 months.
- Concomitant use of medications that are reported to exacerbate rosacea, such as topical and systemic steroids as these may impact assessments.
- Current drug or alcohol abuse.
- 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.
- 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.
- Subjects who are pregnant or planning a pregnancy.
- Use of any investigational therapy within the past 4 weeks.
- Known hypersensitivity or previous allergic reaction to clindamycin or retinoids
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT00823901
Start Date
February 1 2009
End Date
October 1 2010
Last Update
June 25 2012
Active Locations (2)
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1
Department of Dermatology - Stanford School of Medicine
Stanford, California, United States, 94305
2
CURTIS - Massachussetts General Hospital
Boston, Massachusetts, United States, 02114