Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study of the Pharmacokinetics, Safety, and Efficacy of ATX-101 (Sodium Deoxycholate for Injection) Intralipomal Injections for the Treatment of Superficial Lipomas
The purpose of this research is to compare the safety and effectiveness of three different
concentrations (amount of study drug in a liquid preparation) of an investigational drug
(sodium deoxycholate for injection) solution against a placebo (a solution that looks
similar but does not have any active drug in it) in the treatment of superficial lipomas.
Sodium deoxycholate for injection is a chemical similar to the one produced by the body. A
lipoma is a fatty lump typically located on the trunk, shoulder, arms and legs. For the
purposes of this study, only lipomas on the trunk, arms, legs or neck will be treated.
(Lipomas on the face, wrists, hands, lower portion of the spine, genitals, ankles or feet
will not be treated.)
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Safety: Laboratory tests, ECG, Medical Evaluations
Stacy R. Smith, M.D.
Therapeutics Clinical Research
United States: Food and Drug Administration