Submental fat.
Conditions
Interventions
Intervention group: At least one and maximum of 3 sessions of treatment with 2 ml of Embella® injectable solution contains 20 mg deoxycholic acid with a minimum interval of 4 weeks. The product is 2
Sponsors
Zist orchid pharmed Company
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAniseh Samadi
Tehran University of Medical Sciences
Outcome results
None listed