Embella (deoxycholic acid) injections to shrink superficial lipomas
Official title: Evaluating the Efficacy and Safety of Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) Injection in the Management of Superficial Lipomas
Run by Espad Pharmed · NCT07014163 · Data updated 2026-11-12
This will test whether injections of Embella (deoxycholic acid) can shrink small, superficial lipomas in adults aged 18 to 65.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Espad Pharmed Industry-sponsored |
| Locations | 2 sites (Tehran, Tehran Province and 1 other locations) |
| Status | Recruiting |
| Started | May 21, 2024 |
| Main results expected | March 20, 2026 |
| Study ends | June 20, 2026 |
| Registry record updated | June 10, 2025 |
| Trial ID | NCT07014163 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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Razi hospital
Tehran, Iran Recruiting -
Orchid Pharmed, Medical Department
Tehran, Tehran Province, Iran Completed
Study contacts
- Principal investigator: Kamran Balighi — Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran.
- Study coordinator: Hamidreza kafi, PHD
- Email: Kafi.H@orchidpharmed.com
- Phone: +982143473000
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Intralesional Ronkyla Plus injection for superficial lipomas and submental fullness
This trial tests whether a new injectable hydrogel drug called Ronkyla Plus can safely shrink superficial lipomas or reduce submental fullness in adults aged 18–65.
-
Treatment of superficial lipomas using radiofrequency ablation
This study is testing if a new heat treatment called radiofrequency ablation can safely remove small fatty tumors called lipomas without causing scars for adults.
-
Treatment of lipomas with cooled sodium chloride injections
This study is testing if cooled saltwater injections can shrink lipomas, which are harmless fat lumps, as a non-surgical option for people looking for cosmetic improvement or symptom relief.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.