Efficacy & Safety of Clindamycin and Tretinoin in Acne
- Conditions
- Acne
- Registration Number
- NCT01111994
- Lead Sponsor
- Callender Center for Clinical Research
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- 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
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Improvement of acne and post inflammatory hyperpigmentation 3 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Callender Center for Clinical Research
🇺🇸Mitchellville, Maryland, United States
Society Hill Dermatology
🇺🇸Philadelphia, Pennsylvania, United States
Callender Center for Clinical Research🇺🇸Mitchellville, Maryland, United States