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 patientâ€™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% (Fabiorâ„¢ 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 formulationâ€™s safety and tolerability.