Efficacy & Safety of Clindamycin and Tretinoin in Acne

Study Overview
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Brief Summary
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The purpose of this study is ascertain the efficacy and safety of Clindamycin Phosphate 1.2% and Tretinoin 0.025% in the treatment of Acne and Post Inflammatory Hyperpigmentation in patients with skin of color.

Detailed Description
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Acne is a chronic disorder of the pilosebaceous glands characterized by inflammatory papules, pustules, opened and closed comedones, cysts and nodules. Post inflammatory hyperpigmentation is a condition in which an inflammation from a disease such as acne, trauma, or abrasion results in areas of the skin with increased melanin content compared to the surrounding skin. There are several treatments available for acne, which include benzoyl peroxide,antibiotics (topical or oral), and topical retinoids (tretinoin, tazarotene, adapalene). Combination therapy, such as topical retinoid and clindamycin, has been shown to be more effective than monotherapy in addressing all pathogenic factors of acne.

Official Title
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Efficacy & Safety of Clindamycin Phosphase 1.2% and Tretinoin 0.025% Gel vs. Vehicle for the Treatment of Acne and Acne-Induced Post Inflammatory Hyperpigmentation in Patients With Skin of Color

Conditions
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Acne

Intervention / Treatment
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* Drug: Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mild to moderate facial acne and mild to moderate post-inflammatory hyperpigmentation Photo skin types IV - VI Ages 12 and older Both sexes Two week washout period for topical anti-acne medications, medicated cosmetics,and bleaching products Thirty day washout period for oral corticosteroids, oral antibiotics,and oral contraceptives Exclusion Criteria: Seborrheic dermatitis PIH of solely dermal origin Acne vulfaris known to be resistant to oral antibiotics Use of erythromycin-containing products Use of neuromuscular blocking agents Pregnancy, breastfeeding, a positive pregnancy test in the office, or plans to become pregnant. Women of childbearing age must use reliable forms of contraception (e.g., abstinence, oral contraceptives, or spermicide and condoms).

Ages Eligible for Study
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Minimum Age: 12 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel|Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel QD for 3 months|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of acne and post inflammatory hyperpigmentation |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hyperpigmentation