The Efficacy and Safety of Azelaic Acid 15% Foam in the Treatment of Facial Acne Vulgaris

June 2018 | Volume 17 | Issue 6 | Original Article | 641 | Copyright © June 2018

Peter W. Hashim MD MHS,a Tinley Chen BA,a Julie C. Harper MD,b and Leon H. Kircik MDa,c,d

aThe Icahn School of Medicine at Mount Sinai, Department of Dermatology, New York, NY bThe Dermatology and Skin Care Center of Birmingham, Birmingham, AL cIndiana University School of Medicine, Indianapolis, IN dPhysicians Skin Care PLLC, Louisville, KY

Background: Azelaic acid demonstrates anti-inflammatory, anti-oxidative, anti-comedogenic, and anti-microbial effects. Azelaic acid 20% cream is currently approved for the treatment of acne vulgaris, and azelaic acid 15% foam has recently been approved for rosacea. Given the favorable tolerability profile of foam preparations, it is reasonable to assume that azelaic acid 15% foam could serve as a viable treatment option for facial acne. Objective: To examine the efficacy and safety of azelaic acid 15% foam in the treatment of moderate-to-severe facial acne Methods: Twenty subjects with moderate-to-severe facial acne vulgaris were enrolled in this two-center, open-label pilot study. All study subjects were treated with azelaic acid 15% foam for 16 weeks. Efficacy analyses were based on the change in facial investigator global assessment (FIGA) and changes in total, inflammatory, non-inflammatory lesion counts between baseline and week 16. Results: There was a significant reduction in FIGA scores from baseline to week 16 (p = .0004), with 84% of subjects experiencing at least a 1 grade improvement, and 63% of subjects achieving a final grade of Clear or Almost Clear. All subjects experienced reductions in inflammatory and total lesion counts by week 16, and 89% of subjects experienced reductions in non-inflammatory lesions. Azelaic acid 15% foam was well tolerated, with almost all instances of erythema, dryness, peeling, oiliness, pruritus, and burning being of mild or trace degree, and most adverse effects resolving by the end of the study. Conclusion: Azelaic acid 15% foam is effective and safe in the treatment of facial acne vulgaris. Given the convenience of foam vehicles, azelaic acid 15% foam should be considered as a viable treatment option for this condition. J Drugs Dermatol. 2018;17(6):641-645.


Acne vulgaris is a common chronic inflammatory skin disorder with a global prevalence reaching as high as 60-80% in individuals 12-25 years of age.1 Although acne is traditionally perceived as a disease affecting adolescents, there is an increasing prevalence of late-onset, recurrent, or persistent acne in post-adolescent females over the age of 25.2,3 The pathogenesis of acne is multifactorial, including abnormal follicular hyperkeratinization, androgen-related sebum overproduction, proliferation of Propionibacterium acnes in pilosebaceous follicles, and subsequent perifollicular inflammation.3,4 Conventional first-line therapies, such as topical retinoids, anti-bacterials, and anti-inflammatory agents, are used to address each major factor in acne formation.Azelaic acid is a naturally occurring, saturated, dicarboxylic acid that targets the major factors implicated in the pathogenesis of acne through its anti-inflammatory, anti-bacterial, and anti-keratinizing actions.5,6 Azelaic acid 20% cream is currently approved for the topical treatment of mild-to-moderate inflammatory acne and has been shown to provide statistically significant reductions in both inflammatory and non-inflammatory lesions in phase III clinical trials.7-10 It provides an especially useful topical treatment for women who are pregnant or breastfeeding (classified as pregnancy risk category B).Although the foam formulation of azelaic acid 15% is currently only approved for the topical treatment of papulopustular rosacea, it is commonly used off-label in the treatment of acne.11 The foam formulation is highly efficacious due to its enhanced drug release and bioavailability.12,13 Importantly, the favorable cosmetic acceptability and tolerability profile of the foam vehicle may enhance treatment compliance and outcomes.10,12 This pilot study aimed to evaluate the efficacy, safety, and tolerability of azelaic acid 15% foam in the treatment of moderate-to-severe facial acne. 


Study Design and Subjects

This 16-week, two-center, open-label study was conducted in patients with moderate-to-severe facial acne. Male and female subjects of any race, 18 years of age or older, were eligible for inclusion in the study if they exhibited moderate-to-severe