This trial is active, not recruiting.

Condition acne
Treatment clindamycin phosphate 1.2% and tretinoin 0.025% gel
Phase phase 4
Sponsor Callender Center for Clinical Research
Collaborator Society Hill Dermatology
Start date November 2009
End date March 2010
Trial size 30 participants
Trial identifier NCT01111994, VDC2009Z


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking double blind (subject, investigator)
Primary purpose treatment

Primary Outcomes

Improvement of acne and post inflammatory hyperpigmentation
time frame: 3 months

Eligibility Criteria

Male or female participants at least 12 years old.

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).

Additional Information

Official title 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
Principal investigator Valerie Callender, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2010.
Information provided to ClinicalTrials.gov by Callender Center for Clinical Research.