An interventional study of Embella (Deoxycholic acid, produced by Espad Pharmed Co.) in Lipoma, sponsored by Espad Pharmed. Recruiting at 2 sites in Iran, Islamic Republic of. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-06-10.
Sponsored by Espad Pharmed · Not applicable, Interventional, and Treatment
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.
22 studies on the registry are indexed under Lipoma; 6 are open to participants now.
This study's planned enrollment of 10 is below the median of 30 across 17 interventional studies indexed under Lipoma.
Browse Lipoma studies →Espad Pharmed is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Having at least one lipoma (based on clinical and sonographic diagnosis), which is accessible for treatment and assessment and is quantifiable along at least 2 perpendicular diameters and lower than 2 centimeter in depth, with the following characteristics:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
During each treatment, 0.1 mL or 0.15 mL of a 10 mg/mL deoxycholic acid solution will be injected into every 1\*1 cm2 of the lipoma using an insulin syringe with a 1cm needle attached (the max volume of injection is 2 cc in each treatment session). Pressure will be applied directly to the site of injection for several seconds to prevent local bleeding and an adhesive dressing will be applied. The injection will be done at visit 1 (day 0) for everyone and at visits 2 (week 4) and 3 (week 8) as touch-up injections if needed (treatment will be continued until the patient is satisfied with the lipoma's response to the injection, for a max of 3 injections).
Device: Embella (Deoxycholic acid, produced by Espad Pharmed Co.)
0.1 mL or 0.15 mL of a 10 mg/mL deoxycholic acid solution will be injected into every 1\*1 cm2 of the lipoma using an insulin syringe with a 1cm needle attached (the max volume of injection is 2 cc in each treatment session).
Percentage of calculated volume change of lipoma in participants
Percentage of calculated volume change from baseline to week 16 based on ultrasound evaluation in participants
Time frame: Baseline and week 16
Percentage of lipoma size change in participants
Percentage of lipoma size change from baseline to week 16 based on both ultrasound evaluation and objective evaluation (using flexible meter) in participants
Time frame: Baseline and week 16
Percentage of participant with lipoma size change more than 50%
Percentage of participant with size change more than 50% from baseline to week 16
Time frame: Baseline and week 16
Score of patient satisfaction
The score is evaluated by the answers of two questions: 1. How satisfied are you with the result of your injections? The scales are from 1 to 5, 1 indicating very dissatisfied, and 5 indicating very satisfied. 2. Knowing what you know now, how likely is it that you would choose this method again for your initial problem? The scales are: 1 indicating very likely, 3 indicating somewhat likely, and 5 indicating unlikely.
Time frame: Week 16
Percentage of participants requiring touch-up injection
Percentage of participants requiring touch-up injection (week 4 and week 8)
Time frame: Week 4 and week 8
Percentage of participants requiring surgical removal
Percentage of participants requiring surgical removal in 4 months after injections
Time frame: Week 16
Number of injections needed to achieve favorable result
Number of injections needed to achieve favorable result
Time frame: Week 16
The change in diameter of lipoma compared to baseline
The change in diameter of lipoma compared to baseline (week 4 and 8) based on ultrasound evaluation
Time frame: Baseline, week 4, and week 8
The change in volume of lipoma compared to baseline
The change in volume of lipoma compared to baseline (week 4 and 8) based on ultrasound evaluation
Time frame: Baseline, week 4, and week 8
The change in depth of lipoma compared to baseline
The change in depth of lipoma compared to baseline (week 4 and 8) based on ultrasound evaluation
Time frame: Baseline, week 4, and week 8
Safety assessment by evaluation of the severity of adverse events (AEs)
The severity of AEs is assessed at all visits, based on the physician's judgment.
Time frame: Screening visit, Visit 1 (Day 0), Visit 2 (week 4), Visit 3 (week 8), Visit 4 (week 16)
Safety assessment by evaluation of the seriousness of adverse events (AEs)
The seriousness of AEs is assessed at all visits, in accordance with the International Council for Harmonization (ICH-E2B) guidelines.
Time frame: Screening visit, Visit 1 (Day 0), Visit 2 (week 4), Visit 3 (week 8), Visit 4 (week 16)
Safety assessment by evaluation of causality of adverse events (AEs)
The causality of AEs is assessed at all visits, based on World Health Organization (WHO) criteria.
Time frame: Screening visit, Visit 1 (Day 0), Visit 2 (week 4), Visit 3 (week 8), Visit 4 (week 16)
Not enrolling at this site.
Plan to share: No — Data produced in the present study are available upon reasonable request from the investigators.
No publications or documents are linked to this record.
Started May 2024 (actual). Primary completion is estimated for Mar 2026, 21 months after the start.
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