Study of Embella Deoxycholic Acid Injection to Treat Superficial Lipomas in Adults Ages 18 to 65

What this Trial Is About

Lipoma is a common, slow-growing tumor made of fat tissue. People seek treatment because of concerns about its growth, appearance, or pressure effects. Surgery is the usual removal method but can cause bleeding, infection, scarring, and recurrence. Other treatments like liposuction, laser, and medicines have been used. This research evaluates Embella, a synthetic deoxycholic acid injection, as a new treatment option for superficial lipomas. Participants will receive injections of Embella, a 10 mgmL deoxycholic acid solution, directly into the lipoma using a small syringe and needle. Each treatment involves injecting 0.1 or 0.15 mL per square centimeter of the lipoma, with a maximum of 2 cc per session. Injections occur at the start day 0, and additional touch-ups may be given at weeks 4 and 8 if needed, up to three total treatments. During the study, participants will be monitored through visits up to week 16. Researchers will measure changes in lipoma volume and size, patient satisfaction, and the need for further injections or surgery. Safety will be checked by assessing any side effects at several visits. The goal is to understand how safe and effective Embella injections are for reducing superficial lipomas.

Evaluating the Efficacy and Safety of Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) Injection in the Management of Superficial Lipomas