Effectiveness and Safety Evaluation of Embella (Deoxycholic Acid, by Espad Pharmed Co.) in Management of Submental Fat

Espad Pharmed

Status: Completed

Conditions: Submental Fullness

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06509438

EMB.ESP.AF. IV.01

Details and patient eligibility

About

Submental fat (SMF) is a factor affecting beauty that makes people feel uncomfortable about themselves. In 2015, deoxycholic acid with the brand name KYBELLA® was approved by the American FDA for treatment of submental fat. The purpose of this study is to evaluate the safety and effectiveness of deoxycholic acid injection with the brand name Embella®, manufactured by Espad Pharmed Company, for treatment of this condition.

Research Objectives

Primary objective:

Effectiveness and safety of Embella® in reducing submental fat

Secondary objective:

Effectiveness assessment of Embella® in improving SMF grading Effectiveness assessment of Embella® in reducing submental fat diameter

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 18 and 65 years.
• Individuals with unwanted submental fat of any severity.
• Ability to comply with visit schedules and study procedures.
• Signed informed consent form and agreement to a 3-month follow-up.

Exclusion criteria

• Any previous intervention for the treatment of submental fat (SMF).
• Specific anatomical features or previous damage to the intervention site (e.g., scars, liposuction, swallowing difficulties, enlarged thyroid or lymph nodes) that could interfere with the assessment of intervention outcomes.
• Evidence of submental enlargment due to reasons other than SMF.
• History of dysphagia.
• Body mass index (BMI) > 30 kg/m².
• Individuals currently on a weight loss program.
• History of allergy to any components of the drug or local anesthetics.
• Presence of any inflammation, active infection, unhealed wounds, or skin lesions in the injection area.
• Use of any anticoagulants, NSAIDs, or any other medications that increase the risk of coagulation disorders within 7 days before injection.
• Unrealistic expectations.
• Pregnant or breastfeeding women.
• Individuals on sodium-restricted diets, such as those with uncontrolled hypertension.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

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

Experimental group

Description:

The intervention included a minimum of one and a maximum of three treatment sessions, of 2 milliliters of Embella (Deoxycholic acid, produced by Espad Pharmed Co.) injectable solution containing 20 milligrams of deoxycholic acid per session, spaced at least 4 weeks apart.

Treatment:

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