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

Обзор

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.

Вмешательства

• Устройство 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).

Первичные конечные точки

• Percentage of calculated volume change of lipoma in participants [Срок оценки: Baseline and week 16]
• Percentage of lipoma size change in participants [Срок оценки: Baseline and week 16]
• Percentage of participant with lipoma size change more than 50% [Срок оценки: Baseline and week 16]
• Score of patient satisfaction [Срок оценки: Week 16]

Вторичные конечные точки (9)

• Percentage of participants requiring touch-up injection [Срок оценки: Week 4 and week 8]
• Percentage of participants requiring surgical removal [Срок оценки: Week 16]
• Number of injections needed to achieve favorable result [Срок оценки: Week 16]
• The change in diameter of lipoma compared to baseline [Срок оценки: Baseline, week 4, and week 8]
• The change in volume of lipoma compared to baseline [Срок оценки: Baseline, week 4, and week 8]
• The change in depth of lipoma compared to baseline [Срок оценки: Baseline, week 4, and week 8]
• Safety assessment by evaluation of the severity of adverse events (AEs) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Screening visit, Visit 1 (Day 0), Visit 2 (week 4), Visit 3 (week 8), Visit 4 (week 16)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Иран · 2 центра

• Orchid Pharmed, Medical Department — Tehran
• Razi hospital — Tehran

Идентификаторы

NCT: NCT07014163 · EMB.ESP.KB.IV.03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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