Efficacy & Safety of Clindamycin and Tretinoin in Acne

Callender Center for Clinical Research

Status and phase

Unknown

Phase 4

Conditions

Acne

Treatments

Drug: Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel

Study type

Interventional

Funder types

Other

Identifiers

VDC2009Z

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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).