Evaluating the efficacy and safety of (Embella®) in management of superficial lipomas
- Conditions
- superficial lipoma.Benign lipomatous neoplasm
- Registration Number
- IRCT20240416061507N2
- Lead Sponsor
- Espad pharmed
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 10
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ipoma 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.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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