Evaluating the Efficacy and Safety of Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) Injection in the Management of Superficial Lipomas

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 Overview

• Status: Recruiting
• Conditions: Lipoma
• Intervention / Treatment: Device: Embella (Deoxycholic acid, produced by Espad Pharmed Co.)

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hamidreza kafi, PHD; Phone Number: +982143473000; Email: Kafi.H@orchidpharmed.com
• Study Contact Backup: Name: Kamran Balighi, Prof. Derm; Email: Kamran.Balighi@yahoo.com

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of, 19947-66411
    • Completed
    • Orchid Pharmed, Medical Department
  • Tehran, Iran, Islamic Republic of
    • Recruiting
    • Razi hospital
    • Contact: Kamran Balighi, Professor; Phone Number: +9852888282

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Men and women aging between 18 to 65 years

2. 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
   • Located on the trunk, upper and lower limbs, far from main and vulnerable neurovascular structures
3. Stable body weight with a body mass index of less than 30 kg/m² in the past three months
4. Signed informed consent
5. Ability to follow study instructions and likely to complete all required visits
6. Agreement to abstain from any treatment for lipomas during the study

Exclusion Criteria:

1. 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.
2. Known allergy or sensitivity to the study medication or its components
3. Females who are pregnant or breastfeeding, or expecting to conceive children within the projected duration of study
4. 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.
5. Previous treatment for lipomas
6. Subjects planning a surgical procedure for lipoma during the study or at any time that may affect the evaluation
7. 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
8. Evidence of recent alcohol or drug abuse
9. Medical and/or psychiatric problems that are severe enough to interfere with the study results
10. Known bleeding disorder or receiving medication that will likely increase the risk of bleeding after injection
11. Having a tendency to develop hypertrophic scarring
12. Having a history of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), hyaluronic acid products, or Streptococcal protein
13. Having an active inflammation, dermatoses, infection, cancerous or precancerous lesion, or unhealed wound in the site of lipoma
14. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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).

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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.	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants requiring touch-up injection	Percentage of participants requiring touch-up injection (week 4 and week 8)	Week 4 and week 8
Percentage of participants requiring surgical removal	Percentage of participants requiring surgical removal in 4 months after injections	Week 16
Number of injections needed to achieve favorable result	Number of injections needed to achieve favorable result	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	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	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	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.	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.	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.	Screening visit, Visit 1 (Day 0), Visit 2 (week 4), Visit 3 (week 8), Visit 4 (week 16)

Collaborators and Investigators

• Sponsor: Espad Pharmed
• Investigators: Principal Investigator: Kamran Balighi, Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran.

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2024
• Primary Completion (Estimated): March 20, 2026
• Study Completion (Estimated): June 20, 2026

Study Registration Dates

• First Submitted: May 20, 2025
• First Submitted That Met QC Criteria: June 9, 2025
• First Posted (Actual): June 10, 2025

Study Record Updates

• Last Update Posted (Actual): June 10, 2025
• Last Update Submitted That Met QC Criteria: June 9, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Neoplasms, Adipose Tissue; Lipoma; Gastrointestinal Agents; Cholagogues and Choleretics; Deoxycholic Acid
• Other Study ID Numbers: EMB.ESP.KB.IV.03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data produced in the present study are available upon reasonable request from the investigators.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No