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A Review of Adapalene in the Treatment of Acne Vulgaris Cynthia E

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A Review of Adapalene in the Treatment of Acne Vulgaris Cynthia E Journal of Adolescent Health 43 (2008) 421–424 Review article A Review of Adapalene in the Treatment of Acne Vulgaris Cynthia E. Irby, B.A.a, Brad A. Yentzer, M.D.a, and Steven R. Feldman, M.D., Ph.D.a,b,c,* aDepartment of Dermatology, Center for Dermatology Research, Wake Forest University School of Medicine; Winston-Salem, North Carolina bDepartment of Public Health Sciences, Center for Dermatology Research, Wake Forest University School of Medicine; Winston-Salem, North Carolina cDepartment of Pathology, Center for Dermatology Research, Wake Forest University School of Medicine; Winston-Salem, North Carolina Manuscript received January 7, 2008; manuscript accepted June 9, 2008 Abstract Topical retinoids help address the early lesions of acne vulgaris. Consensus guidelines advocate the use of topical retinoids as the primary treatment for most forms of acne vulgaris. However, all topical retinoid preparations may be irritating, and this may contribute to underutilization in clinical practices. Topical adapalene fosters topical retinoid treatment of acne with less irritation. Adapalene is a more stable molecule than tretinoin. Adapalene can be used without concern for photo- deactivation. Because of its chemical stability, adapalene can be used in combination with benzoyl peroxide products. The availability of a stable topical retinoid associated with little irritation may facilitate meeting acne treatment consensus guidelines. © 2008 Society for Adolescent Medicine. All rights reserved. Keywords: Topical retinoids; Tretinoin; Comedolytic; Anti-inflammatory; Pediatricians The pathophysiology of acne involves four key mecha- palene is a third generation retinoid with minimal side nisms of action: abnormal proliferation and differentiation of effects. Adapalene has become widely used because of its keratinocytes, increased sebum production, hyperproliferation comparable efficacy and favorable tolerability profile when of Propionibacterium acnes, and an inflammatory response compared with other topical retinoids [2,3]. initiated by bacterial antigens and cytokines. Topical retinoids target the abnormal proliferation and differentiation of keratin- Adapalene for Treatment of Acne Vulgaris ocytes and also have anti-inflammatory effects. In addition, topical retinoids enhance penetration of other agents, such as Indications and use topical antibiotics, resulting in synergistic effects [1–3]. Retinoids used for acne therapy include tretinoin, tazaro- Adapalene is available in two formulations: gel (.1%, tene, adapalene, and isotretinoin (systemic). Topical retin- .3%) and cream (.1%). After washing with a gentle cleanser, oids are comedolytic and are successful at inhibiting the a thin layer should be applied once daily in the evening to formation of micro-comedones, the precursor to all acne the entire face and any other affected area approved by the lesions. The first-generation retinoids (retinol, tretinoin, and physician [4]. Special care should be taken to avoid the isotretinoin) are irritating, and may limit compliance. Ada- eyes, lips, mucous membranes, and other sensitive areas [4]. As retinoids may increase photosensitivity, patients should be instructed to minimize sun exposure and to apply a Potential conflicts of interest: Dr. Feldman has received research, noncomedogenic sunscreen every morning. The safety and speaking and/or consulting support from several manufacturers of topical Ͻ retinoids including Galderma, OrthoNeutrogena, and Stiefel. The Center efficacy in children 12 years of age have not been deter- for Dermatology Research is supported by an educational grant from mined [5]. Adapalene is pregnancy category C and should Galderma Laboratories, L.P. Dr. Yentzer and Ms. Irby have no conflicts to be used with caution in pregnant women. disclose. *Address correspondence to: Steven R. Feldman, M.D., Ph.D., Depart- Description and clinical pharmacology ment of Dermatology, Wake Forest University School of Medicine, Med- ical Center Boulevard, Winston-Salem, NC 27157-1071. Adapalene’s chemical structure is more stable to light E-mail address: [email protected] and oxidation compared with tretinoin. In an in vitro 1054-139X/08/$ – see front matter © 2008 Society for Adolescent Medicine. All rights reserved. doi:10.1016/j.jadohealth.2008.06.005 422 C.E. Irby et al. / Journal of Adolescent Health 43 (2008) 421–424 study of adapalene and tretinoin, 95% of tretinoin was Another 12-week study compared adapalene .1% gel to degraded within 24 hours in the presence of sunlight and tretinoin .1% microsphere. At week 4, a greater reduction in benzoyl peroxide, whereas adapalene had essentially no non-inflammatory lesions was observed for the tretinoin degradation under these conditions, even at 72 hours .1% microsphere; however the tretinoin group also had a [3,6]. Unlike generic tretinoin gel, adapalene is formu- greater incidence of skin irritation. Both products had sim- lated in an aqueous gel, which may account for some of ilar efficacies (33% vs. 35% mean total lesion reduction) by the improved tolerability. However, adapalene is also week 12 [12]. better tolerated than other formulations of tretinoin A new formulation of adapalene in a .3% gel is now (cream and microsphere gel) [7]. available and is even more effective than its .1% predeces- A proposed mechanism for adapalene’s greater tolerabil- sor. Compared with adapalene .1% gel, adapalene .3% gel ity is its selective binding affinity. Unlike tretinoin, ada- showed greater median percent reduction in total lesion palene does not bind to the cytosolic retinoic acid binding (56% vs. 48%; p ϭ .020) and inflammatory lesion counts proteins but instead selectively binds to the nuclear retinoic (63% vs. 58%; p ϭ .015) [13]. Both concentration per- acid receptor (RAR) subtypes ␤ and ␥ [3,8]. This selective formed significantly better than gel vehicle (p Ͻ .001). binding affinity may play a role in adapalene’s greater Currently, there are no head-to-head efficacy comparisons inhibition of keratinocyte differentiation than tretinoin, of adapalene .3% gel to tretinoin gel, cream, or microsphere. which was demonstrated in a study using keratinocyte trans- glutaminase expression as a marker [3]. This inhibition of The value of adapalene for maintenance therapy was keratinocyte differentiation and proliferation is responsible established in a multicenter, randomized, investigator- for adapalene’s comedolytic effect. In an in vivo study, blinded study with a total of 253 subjects. The subjects were adapalene’s ability to reduce comedone formation was dem- successfully treated (at least 50% improvement from base- onstrated by a 50–60% reduction in comedone counts com- line) in a previous 12-week study, and were randomized to pared with vehicle [9]. receive adapalene .1% gel or gel vehicle once daily for 16 Another important factor in acne pathogenesis is the weeks. Adapalene maintenance therapy resulted in higher inflammation that occurs after microcomedone formation. rates of maintaining at least 50% improvement (75% vs. Adapalene inhibits the inflammatory response to micro- 54%; p Ͻ .001) and significantly lower lesion counts com- comedone formation and bacterial antigens [1,2]. Ada- pared with gel vehicle [14]. palene’s anti-inflammatory effects result from inhibition of Because of the chemical stability of adapalene, it is well neutrophil chemotaxis and the lipoxygenase pathyway, both suited for use in combination with other topicals such as of which are associated with cutaneous inflammatory reac- benzoyl peroxide or antibiotics. The effectiveness of ada- tions [2,8]. Adapalene is more effective at inhibiting neu- palene in combination therapy for the treatment of mild to trophil lipoxygenase than is tretinoin [2,8]. Adapalene also severe acne vulgaris was determined in several studies. In a has other unique anti-inflammatory mechanisms that may multicenter, randomized, investigator-blinded study with a contribute to its efficacy [8]. total of 249 subjects, the efficacy and tolerability of the combination of adapalene .1% gel and topical clindamycin .1% lotion was compared with topical clindamycin .1% Clinical Studies of Adapalene lotion and gel vehicle for the treatment of mild to moderate Clinical efficacy acne. The subjects applied adapalene or vehicle gel once daily in the evening, and topical clindamycin twice daily for Adapalene is an effective acne treatment. A multicenter, 12 weeks. The combination of adapalene and topical clin- randomized, investigator-blinded study with 297 enrolled damycin was more effective than topical clindamycin alone patients compared the efficacy of adapalene .1% solution to in reducing the total lesions (46.7% vs. 25.5%, p Ͻ .001), that of tretinoin .025% gel in a once-daily dosage regimen p ϭ for 12 weeks. Both agents provided significant mean im- inflammatory lesions (55.0% vs. 44.2%, .004), and Ͻ provements in inflammatory lesions (47% and 50%, respec- non-inflammatory lesions (42.5% vs. 16.3%, p .001) tively), and noninflammatory lesions (57% and 54%) [10]. [15]. In another multicenter, randomized, investigator- In another multicenter, randomized, investigator-blinded blinded study, 467 patients with severe acne were random- study, 105 patients with mild to moderate acne vulgaris ized to receive either the combination of adapalene .1% gel were treated with adapalene .1% gel versus tretinoin .025% and oral doxycycline or gel vehicle and oral doxycycline for gel for 3 months. Adapalene gel was found to be more a duration of 12 weeks. Compared with oral doxycyline
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