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...improve or hasten efficacy outcomes. The goal of this study was to compare the efficacy and safety of 2 daily regimens for the treatment of acne: adapalene 0.1% gel for 12 weeks and adapalene 0.1% gel for 6 weeks followed by tazarotene 0.1% cream for 6 weeks. The primary efficacy outcome was the percent of reduction in total lesion counts posttreatment. Subjects ages 12 to 35 years with acne vulgaris were selected to participate in a 12-week, randomized, evaluator-blind study of once-daily therapy with adapalene 0.1% gel (n=101) or "switch therapy," adapalene 0.1% gel followed by tazarotene 0.1% cream (n=100). Adapalene-treated subjects achieved similar percent reductions in total lesion counts at week 12 compared to subjects receiving switch therapy, demonstrating the noninferiority of adapalene get treatment (median difference: -3.57%; lower confidence limit [LQL]: -11.25). Adapalene gel was associated with fewer reports of cutaneous irritation, particularly for scaling and stinging/burning, and fewer treatment-related adverse events compared to switch therapy. The results of this study indicate that daily therapy with adapalene 0.1% gel for 12 weeks was noninferior to switch therapy.

Introduction

Acne vulgaris is a chronic skin disease affecting approximately 80% of young adults and adolescents. (1) The management of acne can be challenging due to the variability in response to treatment and the need for long-term therapy. (2) (3) If not appropriately treated, acne may cause serious physical and emotional scarring and can significantly impact the quality of life of those affected by the disease. (4) (8)

The Global Alliance to Improve Outcomes in Acne published practice guidelines for the treatment of acne in 2005. (4) According to these guidelines, topical retinoids, either alone or in combination with other medications, should be considered first-line therapies for acne. Guidelines from the American Academy of Dermatology (AAD) also emphasize the strong level of evidence for the use of topical retinoids in acne management. (9) Adapalene gel and tazarotene cream are topical retinoids that have been an integral part of topical acne treatment strategies for many years. (10) (12) Efficacy profiles for adapalene gel and tazarotene cream are similar, however adapalene gel is generally associated with better cutaneous tolerability.(2) (10) (13) (14)

Many physicians initiate retinoid therapy with adapalene gel because of its favorable tolerability profile; however, in many cases, patients are switched to a retinoid perceived to be more efficacious at follow-up visits. Reasons given for the switch in retinoids typically involve impatience on the part of patients for the treatment to produce visible results quickly. The physicians reported that by switching treatments patients have a renewed hope for acne clearance. Improvement in the latter half of the treatment course may be due to the new medication or simply a cumulative effect from several weeks of retinoid therapy.

In order to test the theory that switching retinoid therapy improves outcomes, a randomized multicenter, 3-arm study was designed to analyze a switch therapy (6 weeks of adapalene gel followed by 6 weeks of tazarotene cream) to compare 12 weeks of consistent therapy of adapalene gel or tazarotene cream. Endpoints for the switch arm included evaluating effectiveness in teducing total acne lesion counts at week 12 and cutaneous tolerability over the course of the 3 different treatment regimens. Subjects were randomized to 1 of 3 treatment arms. The results of 2 of these arms, the adapalene and switch arms, were compiled and then compared for efficacy and tolerability of treatment.

Methods

The study was a phase 4, randomized, controlled, evaluator-blind, parallel-arm, multicenter trial designed to evaluate and compare the efficacy and safety of 2 acne regimens: adapalene 0.1% gel daily for 12 weeks (adapalene arm) and adapalene 0.1% gel...

NOTE: All illustrations and photos have been removed from this article.



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