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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Embella (Deoxycholic acid, produced by Espad Pharmed Co.) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Embella (Deoxycholic acid, produced by Espad Pharmed Co.) | Device | 2 milliliters of Embella injectable solution containing 20 milligrams of deoxycholic acid |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 4 after the last injection, up to 12 weeks, and week 12 after the last injection, up to 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Submental Fat Thickness | Using calipers | Week 4 after the last injection, up to 12 weeks, and week 12 after the last injection, up to 20 weeks |
| Pain Intensity Was Assessed Using the VAS From 0 to 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Research and Training in Skin Diseases and Leprosy | Tehran | 1416613675 | Iran |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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 | Posted | Count of Participants | Participants | Week 4 after the last injection, up to 12 weeks, and week 12 after the last injection, up to 20 weeks |
|
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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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site tenderness | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hamidreza Kafi | EspadPharmed | +989129232594 | Kafi.h@orchidpharmed.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 20, 2022 | Aug 5, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 20, 2022 | Aug 27, 2025 | SAP_001.pdf |
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before/after clinical trial
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Visual Analogue Scale (VAS): pain intensity scale where 0 indicates no pain and 10 indicates the maximum pain imaginable
| Day 1, week 4 and week 8 |
| 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 | Week 4 after the last injection, up to 12 weeks, and week 12 after the last injection, up to 20 weeks |
| Number of Participants With Adverse Events Immediately After the Injections and During the Study Period | Safety assessment: number of participants with adverse events | 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 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Measurement of Submental Fat Thickness | Using calipers | 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 | Posted | Median | Full Range | Centimeters | 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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| 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 | 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. | Posted | Mean | Full Range | units on a scale | Day 1, week 4 and week 8 |
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| 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 | 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 | Posted | Mean | Full Range | units on a scale | 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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| Secondary | Number of Participants With Adverse Events Immediately After the Injections and During the Study Period | Safety assessment: number of participants with adverse events | All subjects that received study treatment are included in the safety population. | Posted | Count of Participants | Participants | 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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| 0 |
| 20 |
| 0 |
| 20 |
| 18 |
| 20 |
| Injection site numbness | General disorders | Systematic Assessment |
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| Injection site swelling | General disorders | Systematic Assessment |
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| Rigidity | General disorders | Systematic Assessment |
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| Globus sensation | General disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Skin laxity | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| 12 weeks after the last injection |
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| <0.001 |
| Difference of medians |
| -0.4 |
| 2-Sided |
| Other |
Compare 12 weeks after the last injection to baseline |
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| week 8 |
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