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
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Boston |
| State: |
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Massachusetts |
| Zip Code: |
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02114 |
| Conditions: |
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Rosacea |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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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
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| NCT ID: |
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NCT00823901 |
| Primary Contact: |
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Principal Investigator
Alexa Kimball, MD, MPH
Massachusetts General Hospital
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| Backup Contact: |
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N/A |
| Location Contact: |
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Boston, Massachusetts 02114
United States
Alexandra B Kimball, MD
Phone: 617-726-5066
Email: harvardskinstudies@partners.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
| Modifications to this listing: |
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