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

NCT07014163 | Recruiting

• 1 other identifier: EMB.ESP.KB.IV.03
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief 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. 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

Outcome Measures

Primary Outcomes (4)

• 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: 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.

  Week 16

Secondary Outcomes (9)

• Percentage of participants requiring touch-up injection

  Week 4 and week 8

• Percentage of participants requiring surgical removal

  Week 16

• Number of injections needed to achieve favorable result

  Week 16

• The change in diameter of lipoma compared to baseline

  Baseline, week 4, and week 8

• The change in volume of lipoma compared to baseline

  Baseline, week 4, and week 8

Study Arms (1)

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).

Device: Embella (Deoxycholic acid, produced by Espad Pharmed Co.)

Interventions

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).

Embella (Deoxycholic acid, produced by Espad Pharmed Co.)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Espad Pharmed: lead

Study Sites (2)

Orchid Pharmed, Medical Department

Tehran, Tehran Province, 19947-66411, Iran

COMPLETED

Razi hospital

Tehran, Iran

RECRUITING

MeSH Terms

Conditions

Lipoma

Condition Hierarchy (Ancestors)

Neoplasms, Adipose Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Kamran Balighi

  Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hamidreza kafi, PHD

CONTACT

+982143473000; Kafi.H@orchidpharmed.com

Kamran Balighi, Prof. Derm

CONTACT

Kamran.Balighi@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: before/after clinical trial

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: June 10, 2025
• Study Start: May 21, 2024
• Primary Completion: March 20, 2026
• Study Completion (Estimated): June 20, 2026
• Last Updated: June 10, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IR (2)