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Flank region fat is a factor affecting beauty that makes people feel uncomfortable about themselves. In 2015, deoxycholic acid was approved by the American FDA for treatment of flank fat. The purpose of this study is to evaluate the efficacy and safety of deoxycholic acid injection with the brand name Embella®, manufactured by Espad Pharmed Company, for treatment of this condition.
The Primary objective of this study was the proportion of participants with grade 1 or higher ("improved, much improved, very much improved") in investigator-assessed Global Aesthetic Improvement Scale (GAIS) at Week 12 Secondary objective was assessment of other efficacy parameters as well as safety of the product
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Embella (Deoxycholic acid, produced by Espad Pharmed Co.) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deoxycholic Acid Injection | Device | The intervention include Deoxycholic acid, SC, 0.15 ml each injection, up to 2-4 ml in each site (2 ml at visit 1 for everyone, and 2 ml at visit 2 unless the patient does not agree) |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants With Grade 1 or Higher ("Improved, Much Improved, Very Much Improved") in Investigator-assessed Global Aesthetic Improvement Scale (GAIS) at Week 12 | A comparison between Week 12 and Baseline standardized photographs will be made by two independent physicians, resulting in a GAIS score from the range +3 (very much improved), +2 (much improved), +1 (improved), 0 (no change), -1 (worse), -2 (much worse), and -3 (very much worse). The average score between the investigators was taken. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Assessment by Evaluation of Adverse Events (AEs) | Number of participants with at least one adverse event (AE). AEs were assessed at all visits. | Up to week 12 |
| The Proportion of Participants With Grade 1 or Higher ("Improved, Much Improved, Very Much Improved") in Investigator-assessed Global Aesthetic Improvement Scale (GAIS) at Week 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Razi hospital | Tehran | 11996-63911 | Iran |
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| ID | Title | Description |
|---|---|---|
| FG000 | Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) | Participants who received intervention including Deoxycholic acid, subcutaneous injection, 0.1-0.15 ml each injection, with a maximum injection volume of 2 mL per flank per session. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) | Deoxycholic Acid Injection: The intervention included Deoxycholic acid, subcutaneous injection, 0.1-0.15 ml each injection, with a maximum injection volume of 2 mL per side per session. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | The Number of Participants With Grade 1 or Higher ("Improved, Much Improved, Very Much Improved") in Investigator-assessed Global Aesthetic Improvement Scale (GAIS) at Week 12 | A comparison between Week 12 and Baseline standardized photographs will be made by two independent physicians, resulting in a GAIS score from the range +3 (very much improved), +2 (much improved), +1 (improved), 0 (no change), -1 (worse), -2 (much worse), and -3 (very much worse). The average score between the investigators was taken. | Posted | Count of Participants | Participants | Week 12 |
|
Baseline, Week 6, Week 12
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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.) | Deoxycholic Acid Injection: The intervention included Deoxycholic acid, subcutaneous injection, 0.1-0.15 ml each injection, with a maximum injection volume of 2 mL per side per session. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site bruising | 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 | Jan 24, 2024 | Nov 15, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 24, 2024 | Nov 15, 2025 | SAP_001.pdf |
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before/after clinical trial
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A comparison between Week 6 and Baseline standardized photographs will be made by two independent physicians, resulting in a GAIS score from the range +3 (very much improved), +2 (much improved), +1 (improved), 0 (no change), -1 (worse), -2 (much worse), and -3 (very much worse). The average score between the investigators was taken. |
| Week 6 |
| Change From Baseline in Ultrasonographic Measurement of Dermal and Hypodermal Thickness on Both Flanks at Weeks 6 and 12 | Baseline, Week 6, Week 12 |
| Changes From Baseline in the Bodyweight (Kg) at Weeks 6 and 12 | Baseline, Week 6, Week 12 |
| Changes From Baseline in Right and Left Thigh Circumference at Weeks 6 and 12 Using a Flexible Tape Measure | Baseline, Week 6, Week 12 |
| Changes From Baseline in Caliper Measurement (mm) of Flank Fat on Each Side at Weeks 6 and 12 | Baseline, Week 6, Week 12 |
| Changes From Baseline in Waist Circumference at Weeks 6 and 12 Using a Flexible Tape Measure | Baseline, Week 6, Week 12 |
| Subject's Satisfaction at Weeks 6 and 12 Using a 10-point Likert Scale | A 10-point Likert scale is used to measure subject's satisfaction, comprising a question followed by a scale with ten choices, going from "1" (Completely dissatisfied) to "10" (Completely satisfied). | Week 6, Week 12 |
| 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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| Units | Counts |
|---|---|
| Participants |
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| Secondary | Safety Assessment by Evaluation of Adverse Events (AEs) | Number of participants with at least one adverse event (AE). AEs were assessed at all visits. | Posted | Count of Participants | Participants | Up to week 12 |
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| Secondary | The Proportion of Participants With Grade 1 or Higher ("Improved, Much Improved, Very Much Improved") in Investigator-assessed Global Aesthetic Improvement Scale (GAIS) at Week 6 | A comparison between Week 6 and Baseline standardized photographs will be made by two independent physicians, resulting in a GAIS score from the range +3 (very much improved), +2 (much improved), +1 (improved), 0 (no change), -1 (worse), -2 (much worse), and -3 (very much worse). The average score between the investigators was taken. | Posted | Count of Participants | Participants | Week 6 |
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| Secondary | Change From Baseline in Ultrasonographic Measurement of Dermal and Hypodermal Thickness on Both Flanks at Weeks 6 and 12 | Posted | Mean | Standard Deviation | mm | Baseline, Week 6, Week 12 |
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| Secondary | Changes From Baseline in the Bodyweight (Kg) at Weeks 6 and 12 | Posted | Mean | Standard Deviation | Kg | Baseline, Week 6, Week 12 |
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| Secondary | Changes From Baseline in Right and Left Thigh Circumference at Weeks 6 and 12 Using a Flexible Tape Measure | Posted | Mean | Standard Deviation | cm | Baseline, Week 6, Week 12 |
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| Secondary | Changes From Baseline in Caliper Measurement (mm) of Flank Fat on Each Side at Weeks 6 and 12 | Posted | Mean | Standard Deviation | mm | Baseline, Week 6, Week 12 |
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| Secondary | Changes From Baseline in Waist Circumference at Weeks 6 and 12 Using a Flexible Tape Measure | Posted | Mean | Standard Deviation | cm | Baseline, Week 6, Week 12 |
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| Secondary | Subject's Satisfaction at Weeks 6 and 12 Using a 10-point Likert Scale | A 10-point Likert scale is used to measure subject's satisfaction, comprising a question followed by a scale with ten choices, going from "1" (Completely dissatisfied) to "10" (Completely satisfied). | Posted | Median | Inter-Quartile Range | score on a scale | Week 6, Week 12 |
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|
| 0 |
| 30 |
| 0 |
| 30 |
| 30 |
| 30 |
| Injection site pain | General disorders | Systematic Assessment |
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| Injection site swelling | General disorders | Systematic Assessment |
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| Injection site pruritus | General disorders | Systematic Assessment |
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| Injection site necrosis | General disorders | Systematic Assessment |
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| injection site urticaria | General disorders | Systematic Assessment |
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| injection site skin tightness | General disorders | Systematic Assessment |
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| Left dermis at baseline |
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| Left dermis at week 6 |
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| Left dermis at week 12 |
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| Right hypodermis at baseline |
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| Right hypodermis at week 6 |
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| Right hypodermis at week 12 |
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| Left hypodermis at baseline |
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| Left hypodermis at week 6 |
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| Left hypodermis at week 12 |
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| Friedman |
| <0.001 |
| Other |
| This statistical analysis pertains to the right hypodermis and evaluates the trend across baseline, Week 6, and Week 12. | Repeated measure | <0.001 | Other |
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| Left thigh at baseline |
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| Left thigh at week 6 |
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| Left thigh at week 12 |
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| Other |
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| Left caliper at baseline |
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| Left caliper at week 6 |
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| Left caliper at week 12 |
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| Other |
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