Title
Deoxycholic Acid Injection for the Treatment of Superficial Lipomas
Phase 1, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Dose-Escalation Study of the Pharmacokinetics, Safety, and Efficacy of ATX-101 (Sodium Deoxycholate for Injection) Intralipomal Injections for the Treatment of Superficial Lipomas
Phase
Phase 1Lead Sponsor
KytheraStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
LipomaIntervention/Treatment
deoxycholic acid ...Study Participants
16The purpose of this research is to compare the safety and effectiveness of 4 different concentrations of deoxycholic acid injection against a placebo in the treatment of superficial lipomas.
A lipoma is a fatty lump typically located on the trunk, shoulder, arms or legs. For the purposes of this study, only lipomas on the trunk, arms, legs, or neck were treated. (Lipomas on the face, wrists, hands, lower portion of the spine, genitals, ankles, or feet were not treated.)
Administered via intralipomal injection.
Administered via intralipomal injection.
Participants received 0.5% deoxycholic acid administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals.
Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals.
Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals.
Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals.
Participants received matching vehicle placebo administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals.
Inclusion Criteria: One or more lipomas, based on clinical diagnosis, which are accessible for treatment and assessment, are quantifiable along at least 2 perpendicular diameters, and have the following characteristics: History of slow growth followed by dormancy, and stable for at least 6 months. Greatest length by greatest perpendicular width between 1 and 16 square centimeters, inclusive Discrete, oval to rounded in shape, not hard or attached to underlying tissue Located on the trunk, arms, legs, or neck Stable body weight with a body mass index of less than 30 kg/m² Signed informed consent Exclusion Criteria: Absence of significant medical conditions that could affect safety History of surgical treatment for lipomas Treatment with an investigational agent within 30 days before ATX-101 treatment
