Actively Recruiting
Evaluating the Efficacy and Safety of Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) Injection in the Management of Superficial Lipomas
Led by Espad Pharmed · Updated on 2025-06-10
10
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Lipoma is a common, slow-growing tumor made of fat tissue. People seek treatment because of concerns about its growth, appearance, or pressure effects. Surgery is the usual removal method but can cause bleeding, infection, scarring, and recurrence. Other treatments like liposuction, laser, and medicines have been used. This research evaluates Embella, a synthetic deoxycholic acid injection, as a new treatment option for superficial lipomas. Participants will receive injections of Embella, a 10 mg/mL deoxycholic acid solution, directly into the lipoma using a small syringe and needle. Each treatment involves injecting 0.1 or 0.15 mL per square centimeter of the lipoma, with a maximum of 2 cc per session. Injections occur at the start (day 0), and additional touch-ups may be given at weeks 4 and 8 if needed, up to three total treatments. During the study, participants will be monitored through visits up to week 16. Researchers will measure changes in lipoma volume and size, patient satisfaction, and the need for further injections or surgery. Safety will be checked by assessing any side effects at several visits. The goal is to understand how safe and effective Embella injections are for reducing superficial lipomas.
CONDITIONS
Brief Title
Evaluating the Efficacy and Safety of Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) Injection in the Management of Superficial Lipomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 to 65 years
- Having at least one clinically and sonographically diagnosed lipoma accessible for treatment and measurable in at least two perpendicular diameters
- Lipoma stable for at least 6 months with slow growth followed by dormancy
- Lipoma size between 4 and 4 square centimeters in length and width and less than 2 cm in depth
- Lipoma is discrete, oval to rounded, not hard or attached to underlying tissue
- Lipoma located on trunk, upper or lower limbs, away from main neurovascular structures
- Stable body weight with body mass index less than 30 kg/m² in the past three months
- Signed informed consent
- Ability to follow study instructions and likely to complete all visits
- Agreement to avoid any other lipoma treatments during the study
You will not qualify if you...
- Medical or physical conditions affecting evaluation of the product's safety or efficacy, including high blood pressure or respiratory, cardiovascular, liver, neurological, or thyroid disorders
- Allergy or sensitivity to the study medication or its components
- Females who are pregnant, breastfeeding, or planning pregnancy during the study
- Current participation or recent participation (within 30 days) in another investigational drug or device study
- Previous treatment for lipomas
- Planning surgical removal of lipoma during the study
- Conditions causing fat tissue abnormalities due to immune diseases or trauma
- Recent alcohol or drug abuse
- Severe medical or psychiatric problems interfering with study results
- Known bleeding disorders or medications increasing bleeding risk
- History of hypertrophic scarring
- Allergy or anaphylaxis to lidocaine, hyaluronic acid products, or Streptococcal protein
- Active infection, inflammation, cancerous or precancerous lesions, dermatoses, or unhealed wounds at lipoma site
- Any condition or situation that may put the participant at significant risk or interfere with study participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 weeks
Participants receive injections of Embella (Deoxycholic acid) into their lipoma. The injections are administered at the initial visit and may be repeated as touch-up injections at weeks 4 and 8 if needed, for a maximum of 3 injections until the participant is satisfied with the lipoma's response.
3 visits (in-person) at Day 0, Week 4, and Week 8
Duration - 8 weeks
Participants are assessed for safety and effectiveness of the treatment at week 16 to evaluate changes in lipoma size and participant satisfaction.
1 visit (in-person) at Week 16
Trial Site Locations
Total: 2 locations
1
Orchid Pharmed, Medical Department
Tehran, Tehran Province, Iran, 19947-66411
Completed
2
Razi hospital
Tehran, Iran
Actively Recruiting
Research Team
H
Hamidreza kafi, PHD
K
Kamran Balighi, Prof. Derm
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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