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Evaluating the efficacy and safety of (Embella®) in management of superficial lipomas

Evaluating the efficacy and safety of Deoxycholic acid injection (Embella®) in management of superficial lipomas

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240416061507N2
Enrollment
10
Registered
2024-07-20
Start date
2024-08-06
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

superficial lipoma. Benign lipomatous neoplasm

Interventions

Only one intervention group: people aged 18-65 years with at least one superficial lipoma (clinically proven and based on ultrasound criteria) who have referred to Razi Hospital and are willing to und

Sponsors

Espad pharmed
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: having at least one lipoma (clinically and sonographically proven) and accessible for diagnostic and therapeutic approaches with at least two vertical axes measurable and with the following conditions:The history of gradual growth, stability in the last 6 months, single and isolated, with an oval to circular shape, without a hard consistency or connection to the underlying tissue, in the areas of the limbs and trunk and away from sensitive vascular-neural structures Weight stability and body mass index less than 30 in the last 3 months Ability to complete the study and follow instructions Informed consent to participate in the study Consent not to undergo any other intervention for lipoma during the study period

Exclusion criteria

Exclusion criteria: Severe medical or psychological conditions that interfere with study results History of hypersensitivity to any of the components of the studied product Pregnancy and breastfeeding History of previous lipoma treatment BMI >?? Patients prone to intravascular volume depletion Evidence of recent alcohol consumption or drug abuse History of bleeding disorders or recent intake (less than 3 weeks) of thrombolytic drugs, anticoagulants, platelet inhibitors, or NSAIDs History of hypertrophic scarring Infection, inflammation, dermatosis, non-healing wound, cancer or precancerous lesions at the lipoma site

Design outcomes

Primary

MeasureTime frame
Lipoma size reduction percentage. Timepoint: At the beginning of the study, before each injection session monthly up to 3 times, one month after the last injection. Method of measurement: Ultrasound.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactKamran Balighi

Tehran University of Medical Sciences

kamran.balighi@yahoo.com+98 21 5288 8282

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026