The Efficacy and Tolerability of Tazarotene Foam, 0.1%, in the Treatment of Acne Vulgaris in 2 Multicenter, Randomized, Vehicle-Controlled, Double-Blind Studies
April 2013 | Volume 12 | Issue 4 | Original Article | 438 | Copyright © 2013
Steven R. Feldman MD PhD,a Cary P. Werner MS,b and Alessandra B. Alió Saenz MDb
aWake Forest University Health Sciences, Winston-Salem, NC
bStiefel, a GSK company, Research Triangle Park, NC
BACKGROUND: Tazarotene 0.1% gel and cream are effective topical treatments for acne. Tazarotene foam, 0.1% was developed to provide an alternative, safe, and effective formulation.
OBJECTIVE: To evaluate efficacy and tolerability of tazarotene foam, 0.1% in adults and adolescents with acne vulgaris.
METHODS: Two randomized, double-blind, vehicle-controlled, parallel-group studies were conducted at 39 centers in the United States and Canada. The first study involved 744 participants and the second 742, aged 12 to 45 years, who were randomized to receive treatment with either tazarotene foam, 0.1% or vehicle foam once daily for 12 weeks. Lesion counts, Investigator's Static Global Assessments (ISGA), and Subject's Global Assessments (SGA) were evaluated at baseline and weeks 2, 4, 8, and 12. Tolerability was monitored throughout the study.
RESULTS: At week 12 in both studies, treatment with tazarotene foam led to greater decreases from baseline in mean absolute and percentage change in lesion counts (noninflammatory, inflammatory, and total), greater proportion of participants with ≥2-grade improvement in ISGA score, and greater proportion of participants with ISGA score of 0 or 1 than vehicle treatment (P<.001 for all). Only application-site skin irritation and dryness were reported by >5% of participants in active treatment groups in both studies.
LIMITATIONS: The efficacy and tolerability of tazarotene foam were not compared directly with those of other formulations.
CONCLUSION: Tazarotene foam, 0.1% significantly reduced the number and severity of acne lesions after 12 weeks and had a safe and acceptable tolerability profile.
J Drugs Dermatol. 2013;12(4):438-446.
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The pathogenesis of acne is multifactorial. Critical components include abnormal follicular keratinocyte desquamation leading to the formation of a follicular plug (microcomedo), increase of sebum production within the pilosebaceous follicle, colonization by Propionibacterium acnes in the sebum, and inflammation.1-4 Topical retinoids, which target comedogenesis and have anti-inflammatory activity, are recommended as first-line therapy for both noninflammatory and inflammatory acne.5 In addition to retinoids, anti-infective agents are commonly used to treat acne.6,7 Acne treatment regimens thus tend to be complex, and adherence to topical treatment is often poor.6 Achieving good treatment adherence in patients with acne, particularly adolescents, is challenging. Characteristics of vehicle formulations contribute to patient acceptance, and treatments should be selected for optimal comfort and compatibility with the patient’s daily routine.
Tazarotene is a retinoid prodrug that has been approved by the US Food and Drug Administration and by Health Canada in gel and cream formulations (Tazorac 0.1%; Allergan, Inc, Irvine, CA) for the treatment of acne vulgaris.5 Topical tazarotene gel and cream formulations reduce the inflammatory and noninflammatory lesions associated with acne, resulting in sustained clinical benefits with limited local adverse events (AEs).5,8-10
Tazarotene foam, 0.1% (Fabior™ Foam; Stiefel, a GSK Company, Research Triangle Park, NC) was formulated in an aqueous based foam vehicle and was approved in the United States for the topical treatment of acne vulgaris11. Foam vehicles have previously been used to deliver a range of topical active agents,12 including corticosteroids in the treatment of psoriasis13 and antibiotics for acne.14,15 Studies that have evaluated the usability profile of other agents formulated as foams vs creams or other vehicles have shown that foam was preferred to cream with regard to ease of application, uniform spreading, stickiness, greasy feeling, and appearance,16 and that patients with psoriasis17-19 and seborrheic dermatitis20 preferred foam applications over other vehicles. Tazarotene foam, 0.1% was developed to provide an alternative ethanol-free formulation that delivers topical retinoid conveniently. The foam delivery system was designed to overcome the aesthetic disadvantages of gels and creams, which have been reported to leave a greasy or sticky residue and can be difficult to apply evenly.12
Two multicenter, randomized phase 3 studies were conducted in participants with moderate to severe acne vulgaris to assess the clinical efficacy of tazarotene foam, 0.1% in comparison with vehicle foam and to evaluate the formulation’s safety and tolerability.