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

METHODS: Study subjects were at least 18 years of age and had moderate (GLS=2) to severe (GLS=3) glabellar lines at maximum frown, on the 4-point photonumeric Glabellar Line Scale (GLS, 0=no lines, 1=mild, 2=moderate, 3=severe). Subjects were randomly assigned in a 3:1 ratio to receive a single treatment (0.1 mL injected into each of 5 target sites in the glabellar region) of either DWP450 (total of 20 U, administered as 4 U/0.1 mL) or Placebo (0.9% saline). Subjects were then followed for 150 days. The primary efficacy endpoint was defined as the proportion of subjects classified as responders on Day 30. This was a composite endpoint based on both the Investigator and subject’s assessments of glabellar lines at maximum frown on the GLS; a subject was a responder only if both independently agreed that a ≥2 point improvement had occurred from Day 0 to Day 30. Safety was evaluated throughout the study.