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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 such as erythromycin and clindamycin, sulfacetamide and benzoyl peroxide. Isotretinoin (Accutane) is also used.

Official Title
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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

Conditions
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Rosacea

Intervention / Treatment
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* Drug: Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel
* Drug: Placebo gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clindamycin/Tretinoin Gel<br>Participants applied Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel on entire face (forehead, nose, chin, cheeks) once daily at night for 12 weeks | Drug: Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel<br>* Applied on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks<br>* Other names: Ziana;|
| Placebo Comparator: Placebo gel<br>Participants applied Placebo gel with no active medication on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks. | Drug: Placebo gel<br>* Applied placebo gel with no active medication to entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Number of Inflammatory Lesions From Baseline to Week 12 | The number of inflammatory lesions (papules and pustules) on the face were counted by a dermatologist at baseline and week 12 for each participant. Change in the number of inflammatory lesions is defined as week 12 values minus the baseline values of the participant. Last observation carried forward (LOCF) method was used for missing values. | Baseline, week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rosacea, clindamycin, tretinoin, clinical study, treatment