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.
Men and women aging between 18 to 65 years
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
Any medical and physical conditions (for example, high blood pressure or respiratory, cardiovascular, liver, neurological, or thyroid disorders) that, in the opinion of the attending physician, affect the evaluation of the efficacy and safety of the product.
Known allergy or sensitivity to the study medication or its components
Females who are pregnant or breastfeeding, or expecting to conceive children within the projected duration of study
Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study and for the duration of the study.
Single group
Embella (Deoxycholic acid, produced by Espad Pharmed Co.)
Device0.1 mL or 0.15 mL of a 10 mg/mL deoxycholic acid solution will be injected into every 1\*1 cm2 of the lipoma using an insulin syringe with a 1cm needle attached (the max volume of injection is 2 cc in each treatment session).
Percentage of calculated volume change of lipoma in participants
Percentage of calculated volume change from baseline to week 16 based on ultrasound evaluation in participants
Percentage of lipoma size change in participants
Percentage of lipoma size change from baseline to week 16 based on both ultrasound evaluation and objective evaluation (using flexible meter) in participants
Percentage of participant with lipoma size change more than 50%
Percentage of participant with size change more than 50% from baseline to week 16
Score of patient satisfaction
The score is evaluated by the answers of two questions: 1. How satisfied are you with the result of your injections? The scales are from 1 to 5, 1 indicating very dissatisfied, and 5 indicating very satisfied. 2. Knowing what you know now, how likely is it that you would choose this method again for your initial problem? The scales are: 1 indicating very likely, 3 indicating somewhat likely, and 5 indicating unlikely.
Percentage of participants requiring touch-up injection
Percentage of participants requiring touch-up injection (week 4 and week 8)
Percentage of participants requiring surgical removal
Percentage of participants requiring surgical removal in 4 months after injections
Number of injections needed to achieve favorable result
Number of injections needed to achieve favorable result
The change in diameter of lipoma compared to baseline
The change in diameter of lipoma compared to baseline (week 4 and 8) based on ultrasound evaluation
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