Embella (deoxycholic acid) injections to shrink superficial lipomas

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

This will test whether injections of Embella (deoxycholic acid) can shrink small, superficial lipomas in adults aged 18 to 65.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Espad Pharmed (Industry-sponsored)
• Locations: 2 sites (Tehran, Tehran Province and 1 other locations)
• Trial ID: NCT07014163 on ClinicalTrials.gov

What this trial studies

This is a single-arm, open-label interventional pre-post study that injects Embella (purified deoxycholic acid) directly into accessible superficial lipomas and measures size changes over time. Participants undergo baseline clinical and sonographic measurements, receive planned injections, and return for follow-up imaging and exam visits to document lipoma reduction and any adverse effects. The protocol restricts treatment to shallow, well-circumscribed lesions located on the trunk or limbs and excludes lesions near major neurovascular structures. Safety and tolerability are monitored through clinical assessments and sonography at the Tehran study sites.

Who should consider this trial

Good fit: Adults 18–65 with at least one small, superficial, well-circumscribed lipoma (stable for ≥6 months, roughly 4 cm² in surface area, <2 cm depth, not attached to underlying tissue, located on trunk or limbs) and BMI under 30 who can attend study visits.

Not a fit: People with deep, hard, or tissue-attached lipomas, lesions close to major neurovascular structures, BMI ≥30, or who cannot travel to the Tehran sites are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this could offer a non-surgical way to shrink small superficial lipomas and reduce the need for excision and scarring.

How similar studies have performed: Deoxycholic acid is FDA-approved for submental fat reduction and has shown effectiveness for localized fat reduction, but controlled evidence specifically targeting lipomas is limited and mostly anecdotal or from small reports.

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 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.
2. Known allergy or sensitivity to the study medication or its components
3. Females who are pregnant or breastfeeding, or expecting to conceive children within the projected duration of study
4. 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.
5. Previous treatment for lipomas
6. Subjects planning a surgical procedure for lipoma during the study or at any time that may affect the evaluation
7. 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
8. Evidence of recent alcohol or drug abuse
9. Medical and/or psychiatric problems that are severe enough to interfere with the study results
10. Known bleeding disorder or receiving medication that will likely increase the risk of bleeding after injection
11. Having a tendency to develop hypertrophic scarring
12. Having a history of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), hyaluronic acid products, or Streptococcal protein
13. Having an active inflammation, dermatoses, infection, cancerous or precancerous lesion, or unhealed wound in the site of lipoma
14. 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 this trial is running

Tehran, Tehran Province and 1 other locations

• Orchid Pharmed, Medical Department — Tehran, Tehran Province, Iran (Completed)
• Razi hospital — Tehran, Iran (Recruiting)

Study contacts

• Principal investigator: Kamran Balighi — Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran.
• Study coordinator: Hamidreza kafi, PHD

Conditions Lipoma