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

June 2017 | Volume 16 | Issue 6 | Original Article | 534 | Copyright © 2017

Lauren K. Hoffman BS,a James Q. Del Rosso DO,b and Leon H. Kircik MDc

aAlbert Einstein College of Medicine, Bronx NY bJDR Dermatology Research/Thomas Dermatology, Las Vegas, NV; Touro University Nevada, Henderson, NV cIndiana University School of Medicine, Indianapolis, IN; Physicians Skin Care, PLLC, Louisville, KY; Icahn School of Medicine at Mount Sinai, New York, NY

Abstract

INTRODUCTION: Truncal acne is often associated with facial acne, but there are fewer options for an effective topical treatment on the trunk. Given the advent of foam formulations with enhanced percutaneous absorption and convenient application due to easy spreadability on skin, the previously held idea that effective treatment of truncal acne requires oral treatment is challenged. Azelaic acid cream has been previously approved for acne vulgaris, thus azelaic acid foam may be a viable treatment option for truncal acne.

STUDY DESIGN: A single-center, open label pilot study was conducted to investigate the efficacy and safety of azelaic acid 15% foam as a treatment modality for moderate truncal acne. Use for facial acne was also allowed and monitored during the study.

RESULTS: Twice-daily application of azelaic acid 15% foam to affected areas resulted in a 1-grade reduction in truncal investigator global assessment (IGA) scores in nearly all patients (16/18). Eight out of 18 patients (44%) were rated as Clear or Almost Clear in the trunk by the end of the study. There were also improvements in facial IGA scores; 9 of 18 patients (50%) exhibited a 1-grade improvement in IGA scores and 11 of 18 were Clear or Almost Clear by the end of the study. A significant reduction in lesion counts was found throughout the study and the medication was well tolerated.

CONCUSION: Azelaic acid 15% foam was effective in treating moderate truncal acne and facial acne in this pilot study. Given the efficacy and convenience of the foam vehicle, azelaic acid may be considered as a viable option for treatment of acne vulgaris, including on the trunk. Further studies are suggested in a larger population of patients, including adult females with acne.

J Drugs Dermatol. 2017;16(6):534-538.

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INTRODUCTION

While truncal acne vulgaris is estimated to occur in about 50-60% of patients who also suffer from facial acne vulgaris, often times it is undertreated.1-2 When confronted about treatment, the majority of patients with truncal acne are in fact interested in receiving therapy.2 However, the use of topical treatment alone is difficult to implement when using traditional vehicles due to the difficulty of covering large body surface areas. This leaves clinicians to rely on oral therapies over topical interventions because it is assumed that oral medications are more effective. While this line of reasoning may hold up with the use of standard creams and gels, it is challenged with the advent of foam formulations. Foam vehicles have been reported to be associated with enhanced ease of use, better adherence, and consequently improved therapeutic results.2-5 Azelaic acid (AzA) is available in several different topical formulations. AzA 20% cream was the initial formulation approved by the Food and Drug Administration (FDA) for treatment of inflammatory acne vulgaris. Due to improvements in percutaneous delivery, azelaic acid was reformulated into a 15% gel. Previous investigations have shown the percutaneous penetration of AzA to be approximately 8-fold greater after application of AzA 15% gel compared with AzA 20% cream.6 It is thought that the new formulation of AzA foam will improve pharmacologic activity due to its rapid dispersal upon application and enhanced percutaneous absorption compared to other vehicle types.7 Azelaic acid 15% foam (Finacea Foam) is FDA approved for the treatment of papulopustular roasacea in individuals that are 18 years of age or older. The current pilot study focuses on the investigation of the efficacy and safety of azelaic acid 15% foam in the treatment of truncal acne.

METHODS

Study Design

A single, center open label pilot study was conducted to investigate the efficacy and safety of azelaic acid 15% foam as a treatment for moderate truncal acne. Male or female subjects of any race, 12 years of age or older, with truncal acne were potentially eligible for the study. To be enrolled in the study, subjects had to have a truncal acne Investigator Global Assessment (IGA) score of 3 or more (Table 1). Patients were required to be capable of providing informed consent and complying with study instructions. 

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