LipomaNCT07014163
Evaluating the Efficacy and Safety of Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) Injection in the Management of Superficial Lipomas
A study testing Embella (Deoxycholic acid, produced by Espad Pharmed Co.) in people with Lipoma, run by Espad Pharmed at 2 sites in Iran.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lipoma
- What is being tested?
- Embella (Deoxycholic acid, produced by Espad Pharmed Co.)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesIran
- Study dates
- 21 May 2024to 20 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aging between 18 to 65 years
- 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:
- History of slow growth followed by dormancy
- Being stable for at least 6 months
- Greatest length by greatest perpendicular width between 4 and 4 square centimeters
- Inclusive discrete, oval to rounded in shape, not hard or attached to underlying tissue
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- Located on the trunk, upper and lower limbs, far from main and vulnerable neurovascular structures
- Stable body weight with a body mass index of less than 30 kg/m² in the past three months
- Signed informed consent
- Ability to follow study instructions and likely to complete all required visits
- Agreement to abstain from any treatment for lipomas during the study
Who cannot join
- Any medical and physical conditions (for example, high blood pressure or respiratory, cardiovascular, liver, neurological, or thyroid disorders) that, in the opinion of the attending physician, affect the evaluation of the efficacy and safety of the product.
- Known allergy or sensitivity to the study medication or its components
- Females who are pregnant or breastfeeding, or expecting to conceive children within the projected duration of study
- Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study and for the duration of the study.
- Previous treatment for lipomas
- Subjects planning a surgical procedure for lipoma during the study or at any time that may affect the evaluation
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- Subjects with volume deficit due to trauma, abnormalities in adipose tissue related to immune-mediated diseases such as generalized lipodystrophy (e.g., juvenile dermatomyositis), partial lipodystrophy (e.g., Barraquer-Simons syndrome) or HIV-related disease
- Evidence of recent alcohol or drug abuse
- Medical and/or psychiatric problems that are severe enough to interfere with the study results
- Known bleeding disorder or receiving medication that will likely increase the risk of bleeding after injection
- Having a tendency to develop hypertrophic scarring
- Having a history of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), hyaluronic acid products, or Streptococcal protein
- Having an active inflammation, dermatoses, infection, cancerous or precancerous lesion, or unhealed wound in the site of lipoma
- Having a condition or being in a situation that, in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Kamran Balighi, Prof. Derm contact
Iran2 sites, 1 recruiting
- Completed
Orchid Pharmed, Medical Department
Tehran, Tehran Province, 19947-66411
- Recruiting
Razi hospital
Tehran
Kamran Balighi, Professor, +9852888282
About this study
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
- Lipoma
- Being tested
- Embella (Deoxycholic acid, produced by Espad Pharmed Co.)
- Medical subject headings
- Lipoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embella (Deoxycholic acid, produced by Espad Pharmed Co.)Device
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).
| Study group | Role | What they receive |
|---|---|---|
| Embella (Deoxycholic acid, produced by Espad Pharmed Co.) | Experimental | 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). Receives: Device: Embella (Deoxycholic acid, produced by Espad Pharmed Co.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Baseline and week 16
Score of patient satisfaction
The score is evaluated by the answers of two questions:
- 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.
- 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.
Measured: Week 16
Secondary outcomes (9)
Percentage of participants requiring touch-up injection
Percentage of participants requiring touch-up injection (week 4 and week 8)
Measured: Week 4 and week 8
Percentage of participants requiring surgical removal
Percentage of participants requiring surgical removal in 4 months after injections
Measured: Week 16
Number of injections needed to achieve favorable result
Number of injections needed to achieve favorable result
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Screening visit, Visit 1 (Day 0), Visit 2 (week 4), Visit 3 (week 8), Visit 4 (week 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start21 May 2024
- Primary completion20 Mar 2026 (estimated)
- Study completion20 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- before/after clinical trial
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Espad Pharmed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kamran Balighi, Principal investigator, Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07014163
- Sponsor's protocol ID
- EMB.ESP.KB.IV.03
- Status last verified
- May 2025
- First submitted
- 20 May 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data produced in the present study are available upon reasonable request from the investigators.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy and Safety of Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) Injection in the Management of Superficial Lipomas
- ClinicalTrials.gov ID
- NCT07014163
- Acronym / sponsor ID
- EMB.ESP.KB.IV.03
- Conditions
- Lipoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Espad PharmedIndustry (pharma, biotech, devices)
- Study start
- 21 May 2024 (actual)
- Primary completion
- 20 Mar 2026 (estimated)
- Study completion
- 20 Jun 2026 (estimated)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- before/after clinical trial
| Arm | Type | Receives |
|---|---|---|
| Embella (Deoxycholic acid, produced by Espad Pharmed Co.) | Experimental | Device: Embella (Deoxycholic acid, produced by Espad Pharmed Co.)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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Men and women aging between 18 to 65 years
- 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:
- Stable body weight with a body mass index of less than 30 kg/m² in the past three months
- Signed informed consent
- Ability to follow study instructions and likely to complete all required visits
Key exclusion criteria (14 listed)
- Any medical and physical conditions (for example, high blood pressure or respiratory, cardiovascular, liver, neurological, or thyroid disorders) that, in the opinion of the attending physician, affect the evaluation of the efficacy and safety of the product.
- Known allergy or sensitivity to the study medication or its components
- Females who are pregnant or breastfeeding, or expecting to conceive children within the projected duration of study
- Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study and for the duration of the study.
- Previous treatment for lipomas
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | Embella (Deoxycholic acid, produced by Espad Pharmed Co.) |
Primary outcome
Percentage of calculated volume change of lipoma in participants
Time frame: Baseline and week 16
Percentage of calculated volume change from baseline to week 16 based on ultrasound evaluation in participants
Percentage of lipoma size change in participants
Time frame: Baseline and week 16
Percentage of lipoma size change from baseline to week 16 based on both ultrasound evaluation and objective evaluation (using flexible meter) in participants
Percentage of participant with lipoma size change more than 50%
Time frame: Baseline and week 16
Percentage of participant with size change more than 50% from baseline to week 16
Score of patient satisfaction
Time frame: Week 16
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.
9 secondary outcomes
Percentage of participants requiring touch-up injection
Time frame: Week 4 and week 8
Percentage of participants requiring surgical removal
Time frame: Week 16
Number of injections needed to achieve favorable result
Time frame: Week 16
The change in diameter of lipoma compared to baseline
Time frame: Baseline, week 4, and week 8
The change in volume of lipoma compared to baseline
Time frame: Baseline, week 4, and week 8
The change in depth of lipoma compared to baseline
Time frame: Baseline, week 4, and week 8
Safety assessment by evaluation of the severity of adverse events (AEs)
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)
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)
Time frame: Screening visit, Visit 1 (Day 0), Visit 2 (week 4), Visit 3 (week 8), Visit 4 (week 16)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Individual participant dataSharing planned: No. Data produced in the present study are available upon reasonable request from the investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kamran Balighi, Prof. Derm contact
Kamran Balighi principal investigator
Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embella (Deoxycholic acid, produced by Espad Pharmed Co.) in people with Lipoma, run by Espad Pharmed at 2 sites in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hamidreza kafi, PHD (+982143473000, Kafi.H@orchidpharmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of calculated volume change of lipoma in participants (time frame: Baseline and week 16). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.