Effectiveness and Safety Evaluation of Embella (Deoxycholic Acid, by Espad Pharmed Co.) in Management of Submental Fat
- Conditions
- Submental Fullness
- Registration Number
- NCT06509438
- Lead Sponsor
- Espad Pharmed
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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.
- 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 enlargement 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Number of Participants With A Minimum of One Grade Improvement in the Standard Submental Fat (SMF) Assessment Grading Week 4 after the last injection, up to 12 weeks, and week 12 after the last injection, up to 20 weeks The scales are from 0 to 4, 0 indicating no localized submental fat and 4 indicating extreme submental convexity
- Secondary Outcome Measures
Name Time Method Measurement of Submental Fat Thickness Week 4 after the last injection, up to 12 weeks, and week 12 after the last injection, up to 20 weeks Using calipers
Pain Intensity Was Assessed Using the VAS From 0 to 10 Day 1, week 4 and week 8 Visual Analogue Scale (VAS): pain intensity scale where 0 indicates no pain and 10 indicates the maximum pain imaginable
Subject Satisfaction Was Assessed Using the VAS From 0 to 10 Week 4 after the last injection, up to 12 weeks, and week 12 after the last injection, up to 20 weeks Visual Analogue Scale (VAS): satisfaction factor scale where 0 indicates complete dissatisfaction and 10 indicates maximum satisfaction
Number of Participants With Adverse Events Immediately After the Injections and During the Study Period Immediately after all of the injections and at week 4 after the last injection, up to 12 weeks, and week 12 after the last injection, up to 20 weeks Safety assessment: number of participants with adverse events
Trial Locations
- Locations (1)
Center for Research and Training in Skin Diseases and Leprosy
🇮🇷Tehran, Iran
Center for Research and Training in Skin Diseases and Leprosy🇮🇷Tehran, Iran