Submental Fullness
Conditions
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
Interventions
2 milliliters of Embella injectable solution containing 20 milligrams of deoxycholic acid
Sponsors
Espad Pharmed
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
before/after clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Iran
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) 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.
Embella (Deoxycholic acid, produced by Espad Pharmed Co.): 2 milliliters of Embella injectable solution containing 20 milligrams of deoxycholic acid | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 3 |
Baseline characteristics
| Characteristic | Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) | — |
|---|---|---|
| Age, Continuous | 44.10 years STANDARD_DEVIATION 11.35 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Iran | 20 participants | — |
| Sex: Female, Male Female | 17 Participants | — |
| Sex: Female, Male Male | 3 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 18 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Number of Participants With A Minimum of One Grade Improvement in the Standard Submental Fat (SMF) Assessment Grading
The scales are from 0 to 4, 0 indicating no localized submental fat and 4 indicating extreme submental convexity
Time frame: Week 4 after the last injection, up to 12 weeks, and week 12 after the last injection, up to 20 weeks
Population: Analysis set includes only participants who had at least one post-baseline assessment of this outcome. One participant withdrew on Day 1 after the first injection due to an adverse event, and three participants were lost to follow-up by Week 12
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) | Number of Participants With A Minimum of One Grade Improvement in the Standard Submental Fat (SMF) Assessment Grading | 4 weeks after the last injection | 15 Participants |
| Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) | Number of Participants With A Minimum of One Grade Improvement in the Standard Submental Fat (SMF) Assessment Grading | 12 weeks after the last injection | 10 Participants |
Secondary
Measurement of Submental Fat Thickness
Using calipers
Time frame: Week 4 after the last injection, up to 12 weeks, and week 12 after the last injection, up to 20 weeks
Population: Analysis set includes only participants who had at least one post-baseline assessment of this outcome. One participant withdrew on Day 1 after the first injection due to an adverse event, and three participants were lost to follow-up by Week 12
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) | Measurement of Submental Fat Thickness | Baseline | 1.85 Centimeters |
| Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) | Measurement of Submental Fat Thickness | 4 weeks after the last injection | 1.40 Centimeters |
| Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) | Measurement of Submental Fat Thickness | 12 weeks after the last injection | 1.45 Centimeters |
p-value: <0.001Wilcoxon (Mann-Whitney)
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Number of Participants With Adverse Events Immediately After the Injections and During the Study Period
Safety assessment: number of participants with adverse events
Time frame: 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
Population: All subjects that received study treatment are included in the safety population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) | Number of Participants With Adverse Events Immediately After the Injections and During the Study Period | 18 Participants |
Secondary
Pain Intensity Was Assessed Using the VAS From 0 to 10
Visual Analogue Scale (VAS): pain intensity scale where 0 indicates no pain and 10 indicates the maximum pain imaginable
Time frame: Day 1, week 4 and week 8
Population: At each post-baseline visit the analysis includes only those participants who actually received an injection at that visit and provided a pain-after-injection assessment. The Day 0 (first) injection was mandatory for all enrolled participants, but all subsequent injections were optional 'touch-up' procedures given only when the investigator judged them necessary. Consequently, numbers analyzed are smaller at later time points.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) | Pain Intensity Was Assessed Using the VAS From 0 to 10 | Day 1 | 5.1 units on a scale |
| Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) | Pain Intensity Was Assessed Using the VAS From 0 to 10 | week 4 | 3.9 units on a scale |
| Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) | Pain Intensity Was Assessed Using the VAS From 0 to 10 | week 8 | 3.0 units on a scale |
Secondary
Subject Satisfaction Was Assessed Using the VAS From 0 to 10
Visual Analogue Scale (VAS): satisfaction factor scale where 0 indicates complete dissatisfaction and 10 indicates maximum satisfaction
Time frame: Week 4 after the last injection, up to 12 weeks, and week 12 after the last injection, up to 20 weeks
Population: Analysis set includes only participants who had at least one post-baseline assessment of this outcome. One participant withdrew on Day 1 after the first injection due to an adverse event, and three participants were lost to follow-up by Week 12
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) | Subject Satisfaction Was Assessed Using the VAS From 0 to 10 | 4 weeks after the last injection | 7.63 units on a scale |
| Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) | Subject Satisfaction Was Assessed Using the VAS From 0 to 10 | 12 weeks after the last injection | 7.43 units on a scale |