Evaluation of an injectable solution with the brand name ®Embella in order to reduce submental fat.
Phase 2
Recruiting
- Conditions
- Submental fat.
- Registration Number
- IRCT20190210042676N29
- Lead Sponsor
- Zist orchid pharmed Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Ages 18 to 65
People with unwanted submental fat with moderate to severe intensity, grades 2 and 3 of the clinical grade of SMF (submental fat) evaluation
Have signed the informed consent form and agree to a 3-month follow-up.
Exclusion Criteria
Any previous intervention to treat submental fat.
Specific anatomical features or previous damage to the intervention site (ulcers, liposuction, difficulty swallowing, enlargement of the thyroid gland or lymph nodes) that interfere with the evaluation of intervention results.
History of dysphagia
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Grading changes in submental fat. Timepoint: Before intervention, 4 and 2 weeks after last injection. Method of measurement: Standard grading evaluation of submental fat (SMF).
- Secondary Outcome Measures
Name Time Method Change in fat diameter of submental area. Timepoint: Before intervention, 4 and 2 weeks after last injection. Method of measurement: Caliper.;Consumer Satisfaction. Timepoint: Before intervention, 4 and 2 weeks after last injection. Method of measurement: Using the Likert scale includes: 0 = not satisfied at all, 1 = slightly satisfied, 2 = moderately satisfied, and 3 = very or extremely satisfied.