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
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 lipoma confirmed by clinical and sonographic diagnosis, accessible for treatment and assessment
- Lipoma must be measurable in at least two perpendicular diameters and less than 2 centimeters in depth
- Lipoma characteristics: slow growth then stable for at least 6 months, size between 4 and 4 square centimeters, discrete oval to rounded shape, not hard or attached to underlying tissue
- Lipoma located on trunk or limbs, away from major nerves and blood vessels
- Stable body weight with body mass index less than 30 kg/m² in past 3 months
- Signed informed consent
- Ability and willingness to follow study instructions and complete all visits
- Agreement to avoid any lipoma treatment during the study
You will not qualify if you...
- Any medical or physical condition that may affect treatment assessment according to the physician
- Known allergy or sensitivity to study medication or its ingredients
- Pregnant, breastfeeding, or planning pregnancy during study period
- Current or recent participation (within 30 days) in another investigational drug or device study
- Previous treatment for lipomas
- Planning surgery for lipoma during study
- Conditions causing fat tissue loss related to immune diseases or HIV
- Recent alcohol or drug abuse
- Severe medical or psychiatric problems interfering with study
- Known bleeding disorders or medications increasing bleeding risk
- Tendency to develop raised scarring
- History of severe allergic reactions to lidocaine, hyaluronic acid products, or Streptococcal protein
- Active inflammation, skin disease, infection, cancer, or unhealed wound at lipoma site
- Any other condition that may pose risk, interfere with results, or participation as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
K
Kamran Balighi, Prof. Derm
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here