Tazarotene 0.1% Cream Superior in Comparison Study With Adapalene

Peggy Peck

March 26, 2003

March 26, 2003 (San Francisco) — Results of a multicenter comparison trial of tazarotene 0.1% topical cream and adapalene 0.1% topical cream for treatment of facial acne vulgaris suggest that tazarotene is superior to adapalene for reduction of comedones.

Alan Shalita, MD, professor of dermatology at the State University of New York Downstate Medical Center in Brooklyn and lead investigator for the multicenter trial, presented the results here on Monday at the 61st annual meeting of the American Academy of Dermatology (AAD). Dr. Shalita said that after 12 weeks of treatment, tazarotene treatment reduced open and closed comedones by an average of 68% compared with a 36% average reduction among patients in the adapalene group.

Moreover, 77% of the tazarotene-treated patients achieved at least a 50% global improvement in acne. This was significantly better than the 55% of adapalene-treated patients who achieved 50% global improvement.

Although the tazarotene results are impressive, it is difficult to assess the results of acne trials, said Nia Terezakis, MD, clinical professor of dermatology at both Tulane and Louisiana State University in New Orleans. "Acne is not one disease and it is hard to get 50 or 100 patients that have the exact same manifestations," explained Dr. Terezakis, who is an AAD spokesperson on acne. Nonetheless, Dr. Terezakis, who was not involved in the study, told Medscape that, "Dr. Shalita is a meticulous researcher," which adds credibility to the results.

For her perspective, Dr. Terezakis said, "retinoids are the best treatment for acne and both of these treatments are retinoids. In my practice, I start patients on a retinoid and if that doesn't work, I try another retinoid since all of them work by shrinking the oil gland and repairing the DNA."

The trial enrolled 173 patients with facial acne vulgaris. All patients were aged 12 years or older and all had a 30-day washout period for systemic medications and a 14-day washout period for topical medications that they may have been taking for acne treatment. For estrogens or birth control pills, the washout was 12 weeks, and for oral retinoids, the washout was 12 months.

Patients were randomized to treatment with tazarotene 0.1% or adapalene 0.1% cream, which they applied to the face once daily every evening for 12 weeks.

Overall, 86% of participants completed the study. Six patients in the tazarotene group and three patients in the adapalene group discontinued therapy prematurely either because of lack of efficacy or adverse events.

Patient ratings of acne improvement were also superior among patients receiving tazarotene versus those receiving adapalene. Differences in patients' baseline levels of inflammatory acne precluded meaningful comparison of inflammatory efficacy, but both drugs were effective at reducing inflammatory lesions.

The most common adverse effects — peeling, burning, itching, redness, and dryness — were relatively rare as well as mild and transient in both groups of patients.

This study was funded by Allergan Skin Care, the maker of tazarotene.

AAD 61st Annual Meeting: Abstract P75. Presented March 24, 2003.

Reviewed by Gary D. Vogin, MD


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