Clinical Trial

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

Recruiting
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Record status
This record was last updated June 10, 2025 (before its estimated March 20, 2026 completion). Its status may not reflect the trial's current state.
Summary
Lipoma is a relatively common, slow-growing mesenchymal neoplasm originating from adipose tissue. Patients seek treatment for lipomas for various reasons, such as concerns about their growth and spread, aesthetic issues, or worries about the compressive effects of the lipoma. Lipomas are typically removed surgically through excision, which can have complications including bleeding, infection, scarring, and recurrence. Other mentioned treatment methods include liposuction, laser, and medicinal approaches. Purified synthetic deoxycholic acid has been introduced as the first pharmacological intervention approved by the FDA for the reduction of submental fat. Deoxycholic acid is a type of bile acid that, due to its ability to cause non-selective cell lysis and disruption of adipocyte membranes (adipocytolysis), leads to emulsification of fat in the intestine. This is an interventional (pre-post), single-arm, and open-label study to evaluate the efficacy and safety of Embella (Deoxycholic acid, produced by Espad Pharmed Co.) for the management of superficial lipomas.
Trial Details
NCT Number NCT07014163
Lead Sponsor Espad Pharmed
Conditions Lipoma
Enrollment 10 participants
Start Date 2024-05-21
Primary Completion 2026-03-20 (estimated)
Study Completion 2026-06-20 (estimated)
Updated on ClinicalTrials.gov 2025-06-10