Efficacy & Safety of Clindamycin and Tretinoin in Acne

Phase 4UnknownNCT01111994

Callender Center for Clinical Research30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Acne

Interventions

Clindamycin Phosphate 1.2% and Tretinoin 0.025% GelDRUG

Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel QD for 3 months

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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).

Locations (2)

Callender Center for Clinical Research

Mitchellville, Maryland, United States

Society Hill Dermatology

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Improvement of acne and post inflammatory hyperpigmentation

Time frame: 3 months

Data from ClinicalTrials.gov

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