IRCT20240416061507N2
Not yet recruiting
Phase 4
Evaluating the efficacy and safety of Deoxycholic acid injection (Embella®) in management of superficial lipomas
Espad pharmed0 sites10 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- superficial lipoma.
- Sponsor
- Espad pharmed
- Enrollment
- 10
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
- •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
Outcomes
Primary Outcomes
Not specified
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