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

Recruiting now · Not applicable

Conditions studied: Lipoma

In brief

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.

Key facts

Study ID: NCT07014163
Run by: Espad Pharmed
People needed: 10
Starts: 2024-05-21
Expected to finish: 2026-06-20
Last updated by the study team: 2025-06-10

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Men and women aging between 18 to 65 years
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
Stable body weight with a body mass index of less than 30 kg/m² in the past three months
Signed informed consent
Ability to follow study instructions and likely to complete all required visits
Agreement to abstain from any treatment for lipomas during the study

You may not qualify if…

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.
Previous treatment for lipomas
Subjects planning a surgical procedure for lipoma during the study or at any time that may affect the evaluation
Subjects with volume deficit due to trauma, abnormalities in adipose tissue related to immune-mediated diseases such as generalized lipodystrophy (e.g., juvenile dermatomyositis), partial lipodystrophy (e.g., Barraquer-Simons syndrome) or HIV-related disease
Evidence of recent alcohol or drug abuse
Medical and/or psychiatric problems that are severe enough to interfere with the study results
Known bleeding disorder or receiving medication that will likely increase the risk of bleeding after injection
Having a tendency to develop hypertrophic scarring
Having a history of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), hyaluronic acid products, or Streptococcal protein
Having an active inflammation, dermatoses, infection, cancerous or precancerous lesion, or unhealed wound in the site of lipoma
Having a condition or being in a situation that, in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study

Where it is running

Razi hospital — Tehran, Iran (enrolling)
Orchid Pharmed, Medical Department — Tehran, Tehran Province, Iran

Full record on ClinicalTrials.gov

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