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NCT Number: NCT07014163

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orchid Pharmed, Medical Department, Tehran, Tehran Province, Iran

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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).

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. Score of patient satisfaction

    Time frame: Week 16

    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.

Secondary outcomes

  1. Percentage of participants requiring touch-up injection

    Time frame: Week 4 and week 8

    Percentage of participants requiring touch-up injection (week 4 and week 8)

  2. Percentage of participants requiring surgical removal

    Time frame: Week 16

    Percentage of participants requiring surgical removal in 4 months after injections

  3. Number of injections needed to achieve favorable result

    Time frame: Week 16

    Number of injections needed to achieve favorable result

  4. The change in diameter of lipoma compared to baseline

    Time frame: Baseline, week 4, and week 8

    The change in diameter of lipoma compared to baseline (week 4 and 8) based on ultrasound evaluation

  5. The change in volume of lipoma compared to baseline

    Time frame: Baseline, week 4, and week 8

    The change in volume of lipoma compared to baseline (week 4 and 8) based on ultrasound evaluation

  6. The change in depth of lipoma compared to baseline

    Time frame: Baseline, week 4, and week 8

    The change in depth of lipoma compared to baseline (week 4 and 8) based on ultrasound evaluation

  7. 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)

    The severity of AEs is assessed at all visits, based on the physician's judgment.

  8. 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)

    The seriousness of AEs is assessed at all visits, in accordance with the International Council for Harmonization (ICH-E2B) guidelines.

  9. 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)

    The causality of AEs is assessed at all visits, based on World Health Organization (WHO) criteria.

Study contacts

Contact information is provided by the study sponsor or research team.

Hamidreza kafi, PHD

CONTACT

[email protected]

+982143473000

Kamran Balighi, Prof. Derm

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Espad Pharmed

Industry

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 10, 2025
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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