Evaluating the Efficacy and Safety of Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) Injection in the Management of Superficial Lipomas
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Men and women aging between 18 to 65 years 2. Having at least one lipoma (based on clinical and sonographic diagnosis), which is accessible for treatment and assessment and is quantifiable along at least 2 perpendicular diameters and lower than 2 centimeter in depth, with the following characteristics: * History of slow growth followed by dormancy * Being stable for at least 6 months * Greatest length by greatest perpendicular width between 4 and 4 square centimeters * Inclusive discrete, oval to rounded in shape, not hard or attached to underlying tissue * Located on the trunk, upper and lower limbs, far from main and vulnerable neurovascular structures 3. Stable body weight with a body mass index of less than 30 kg/m² in the past three months 4. Signed informed consent 5. Ability to follow study instructions and likely to complete all required visits 6. Agreement to abstain from any treatment for lipomas during the study Exclusion Criteria: 1. Any medical and p