Evaluating the Efficacy and Safety of Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) I… (NCT07014163) | Clinical Trial Compass
RecruitingNot Applicable
Evaluating the Efficacy and Safety of Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) Injection in the Management of Superficial Lipomas
Iran10 participantsStarted 2024-05-21
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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:
✓. 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
What they're measuring
1
Percentage of calculated volume change of lipoma in participants
Timeframe: Baseline and week 16
2
Percentage of lipoma size change in participants
Timeframe: Baseline and week 16
3
Percentage of participant with lipoma size change more than 50%
✕. 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