Trial Outcomes & Findings for Effectiveness and Safety Evaluation of Embella (Deoxycholic Acid, by Espad Pharmed Co.) in Management of Submental Fat (NCT NCT06509438)
NCT ID: NCT06509438
Last Updated: 2025-09-19
Results Overview
The scales are from 0 to 4, 0 indicating no localized submental fat and 4 indicating extreme submental convexity
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Week 4 after the last injection, up to 12 weeks, and week 12 after the last injection, up to 20 weeks
Results posted on
2025-09-19
Participant Flow
Participant milestones
| Measure |
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
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|---|---|
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Overall Study
STARTED
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20
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Overall Study
COMPLETED
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16
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Overall Study
NOT COMPLETED
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4
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Reasons for withdrawal
| Measure |
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
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|---|---|
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Overall Study
Adverse Event
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1
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Overall Study
Lost to Follow-up
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3
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.)
n=20 Participants
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
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|---|---|
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Age, Continuous
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44.10 years
STANDARD_DEVIATION 11.35 • n=20 Participants
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Sex: Female, Male
Female
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17 Participants
n=20 Participants
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Sex: Female, Male
Male
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3 Participants
n=20 Participants
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Region of Enrollment
Iran
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20 participants
n=20 Participants
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PRIMARY outcome
Timeframe: Week 4 after the last injection, up to 12 weeks, and week 12 after the last injection, up to 20 weeksPopulation: 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
The scales are from 0 to 4, 0 indicating no localized submental fat and 4 indicating extreme submental convexity
Outcome measures
| Measure |
Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.)
n=19 Participants
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
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|---|---|
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Number of Participants With A Minimum of One Grade Improvement in the Standard Submental Fat (SMF) Assessment Grading
4 weeks after the last injection
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15 Participants
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Number of Participants With A Minimum of One Grade Improvement in the Standard Submental Fat (SMF) Assessment Grading
12 weeks after the last injection
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10 Participants
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SECONDARY outcome
Timeframe: Week 4 after the last injection, up to 12 weeks, and week 12 after the last injection, up to 20 weeksPopulation: 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
Using calipers
Outcome measures
| Measure |
Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.)
n=20 Participants
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
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|---|---|
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Measurement of Submental Fat Thickness
Baseline
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1.85 Centimeters
Interval 1.6 to 2.7
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Measurement of Submental Fat Thickness
4 weeks after the last injection
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1.40 Centimeters
Interval 1.4 to 1.8
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Measurement of Submental Fat Thickness
12 weeks after the last injection
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1.45 Centimeters
Interval 1.4 to 1.9
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SECONDARY outcome
Timeframe: Day 1, week 4 and week 8Population: 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.
Visual Analogue Scale (VAS): pain intensity scale where 0 indicates no pain and 10 indicates the maximum pain imaginable
Outcome measures
| Measure |
Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.)
n=20 Participants
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
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|---|---|
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Pain Intensity Was Assessed Using the VAS From 0 to 10
Day 1
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5.1 units on a scale
Interval 1.0 to 9.0
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Pain Intensity Was Assessed Using the VAS From 0 to 10
week 4
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3.9 units on a scale
Interval 1.0 to 9.0
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Pain Intensity Was Assessed Using the VAS From 0 to 10
week 8
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3.0 units on a scale
Interval 1.0 to 9.0
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SECONDARY outcome
Timeframe: Week 4 after the last injection, up to 12 weeks, and week 12 after the last injection, up to 20 weeksPopulation: 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
Visual Analogue Scale (VAS): satisfaction factor scale where 0 indicates complete dissatisfaction and 10 indicates maximum satisfaction
Outcome measures
| Measure |
Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.)
n=19 Participants
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
|
|---|---|
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Subject Satisfaction Was Assessed Using the VAS From 0 to 10
4 weeks after the last injection
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7.63 units on a scale
Interval 1.0 to 10.0
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Subject Satisfaction Was Assessed Using the VAS From 0 to 10
12 weeks after the last injection
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7.43 units on a scale
Interval 1.0 to 10.0
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SECONDARY outcome
Timeframe: 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 weeksPopulation: All subjects that received study treatment are included in the safety population.
Safety assessment: number of participants with adverse events
Outcome measures
| Measure |
Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.)
n=20 Participants
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
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|---|---|
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Number of Participants With Adverse Events Immediately After the Injections and During the Study Period
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18 Participants
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Adverse Events
Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.)
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.)
n=20 participants at risk
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
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|---|---|
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General disorders
Injection site tenderness
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65.0%
13/20 • Number of events 19 • 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
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General disorders
Injection site numbness
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35.0%
7/20 • Number of events 9 • 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
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General disorders
Injection site swelling
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20.0%
4/20 • Number of events 5 • 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
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General disorders
Rigidity
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10.0%
2/20 • Number of events 3 • 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
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General disorders
Globus sensation
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5.0%
1/20 • Number of events 2 • 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
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Respiratory, thoracic and mediastinal disorders
Cough
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5.0%
1/20 • Number of events 1 • 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
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Skin and subcutaneous tissue disorders
Skin laxity
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5.0%
1/20 • Number of events 1 • 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
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place