Abstract: Alopecia in Male Patients Treated with ATX-101 (Deoxycholic Acid) for Submental Fullness

Abstract

INTRODUCTION: Deoxycholic acid is approved for minimally invasive treatment of submental fat. Safety profiles from pivotal studies did not report on the potential adverse effect of localized alopecia.1,2 Knowledge about any potential adverse event, including alopecia, is important for informed consent and setting patient expectations. This study is the first to characterize alopecia in patients undergoing deoxycholic acid treatment for submental fat. METHODS: A retrospective review was conducted of 171 patients (66 male) treated with deoxycholic acid in the submental region at a single-center between January 2015-December 2016. Deoxycholic acid was injected into the preplatysmal submental fat (0.2 mL per injection of 10mg/mL to achieve a dose of 2mg/cm2) for a maximum of 6 treatments. Patient characteristics, treatment plan, and severity/resolution of alopecia was analyzed. RESULTS: Alopecia was reported in 15% of male patients (none observed in female patients). Severity of alopecia in follow-up patients (n=8) ranged from diffuse/mild to 6 patches of alopecia, and was not associated with dose delivered or number of injections. Alopecia was noticed a median 31.5 days after injection (range 15–94 days). Five of eight patients reported improvement or complete resolution of alopecia. Six of eight patients experienced alopecia after the first treatment. Five of eight patients seeked further treatment despite alopecia. CONCLUSION: Alopecia is a real adverse event following treatment of deoxycholic acid for submental fat reduction in males that occurs approximately 1 month after treatment. Severity is not dependent on treatment plan, and is likely due to patient characteristics. While a majority of patients had improvement or resolution, longer follow-up is needed to further assess the transiency of injection-induced alopecia. Importantly, a majority of patients continued to seek further treatment, suggesting patient-impact of this alopecia was low compared to the benefits of submental fat reduction. Reference Citations: 1. Kythera Biopharmaceuticals I. Dermatologic and ophthalmic drugs advisory committee briefing document: ATX-101 (deoxycholic acid) injection. https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DermatologicandOphthalmicDrugsAdvisoryCommittee/UCM436604.pdf. Accessed February 26, 2017. 2. Dayan SH, Humphrey S, Jones DH, et al. Overview of ATX-101 (Deoxycholic Acid Injection): A Nonsurgical Approach for Reduction of Submental Fat. Dermatol Surg. 2016;42:S263-S270.