Dermatology Education Initiative - Topical Acne Treatments Express Report

The 65^th Annual Meeting of the American Academy of Dermatology and the 31^st Hawaii Dermatology Seminar

Publication date: 2007-05-14

Novel Topical Formulation for Acne Vulgaris: A Focus on Efficacy

This report was reviewed for medical and scientific accuracy by Amy S. Paller, MD, Professor and Chair of Dermatology, Professor of Pediatrics, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.

This Topical Acne Treatments Express Report™ reviews data on a novel new gel formulation of clindamycin phosphate 1.2%/tretinoin 0.025% (Ziana) presented in 2007 at the 65^th Annual Meeting of the American Academy of Dermatology and the 31^st Hawaii Dermatology Seminar. According to the data presented, clindamycin phosphate 1.2%/tretinoin 0.025% gel was statistically significantly more effective than clindamycin phosphate 1.2% gel, tretinoin 0.025% gel, and vehicle gel in reducing the number of inflammatory, non-inflammatory and total lesion counts from baseline. Similarly, a subgroup analysis of patients aged 12 to 18 years demonstrated significantly greater reductions in inflammatory, non-inflammatory and total lesions compared with clindamycin phosphate 1.2% gel, tretinoin 0.025% gel, and vehicle gel for all baseline severities combined (mild, moderate, severe). The results of studies reviewed in this report suggest that the novel formulation of once-daily clindamycin phosphate 1.2%/tretinoin 0.025% gel is safe and effective for the short- and long-term treatment of acne vulgaris compared to monotherapy with clindamycin phosphate 1.2% gel or tretinoin 0.025% gel.

Expert Commentary

Provided by

Diane Berson, MD, FAAD, Assistant Professor of Dermatology at the Weill Medical College of Cornell University; Assistant Attending Dermatologist, New York-Presbyterian Hospital; New York, New York

Acne affects between 40 and 50 million individuals in the United States. ¹ Although acne is typically associated with adolescence, affecting 79% to 95% of 16- to 18-year-old adolescents, ^2-4 acne may also affect children and adults. In 10- to 12-year-old children, acne affects from 28% to 61% of individuals. ^2-4 In adults older than 25 years, 54% of women and 40% of men exhibit some degree of facial acne, with symptoms persisting into middle age. ⁵

There are many safe and effective therapeutic options to treat pediatric, adolescent, and adult patients with acne vulgaris. Topical therapies for treating acne vulgaris include benzoyl peroxide, topical retinoids (tretinoin, adapalene, and tazarotene), and topical antibiotic agents (azelaic acid, erythromycin, clindamycin, sodium sulfacetamide). Systemic therapies include systemic antibiotic agents (erythromycin, tetracycline, doxycycline, minocycline), hormonal therapy (oral contraceptives, spironolactone), and oral isotretinoin. The goal of acne therapy is to reduce the severity of disease; therefore, therapy should be individualized to the patient, with reliance on topical and systemic therapies that are prescribed based on the severity of acne.⁶ In addition, treatment should be achieved using efficacious agents offering durable therapeutic responses and a low-risk of short- and long-term adverse effects. ⁷

Because of systemic adverse effects associated with oral therapies, initial therapy for acne vulgaris typically consists of benzoyl peroxide, topical antibiotics, topical retinoids or a combination of topical agents (eg, benzoyl peroxide/clindamycin, erythromycin/tretinoin). Benzoyl peroxide is fully active against sensitive and resistant propionibacteria, thus its concomitant use with other topical agents may counteract the development of resistant bacteria. ⁷ Topical antibiotics are available in a variety of formulations (eg, lotion, cream, solution, gel) and should be tailored to the patient's skin type. Topical retinoids are appropriate for non-inflammatory comedonal acne, while patients with inflammatory lesions and comedones may respond best to a combination of topical retinoid and topical or oral antibiotic. ⁸ However, until recently, the combination of topical retinoid and topical antibiotic in a single form