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Efficacy & Safety of Clindamycin and Tretinoin in Acne

Information source: Callender Center for Clinical Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acne

Intervention: Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Callender Center for Clinical Research

Official(s) and/or principal investigator(s):
Valerie Callender, MD, Principal Investigator, Affiliation: Callender Center for Clinical Research


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Improvement of acne and post inflammatory hyperpigmentation

Detailed 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.


Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.


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 and Contacts

Callender Center for Clinical Research, Mitchellville, Maryland 20721, United States

Society Hill Dermatology, Philadelphia, Pennsylvania 19107, United States

Additional Information

Home page to the Callender Skin & Laser Center that includes "Research Studies" section

Starting date: November 2009
Last updated: May 19, 2010

Page last updated: August 23, 2015

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