Trial Outcomes & Findings for Evaluating the Efficacy and Safety of Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) for the Treatment of Flank Fat (NCT NCT07004010)
NCT ID: NCT07004010
Last Updated: 2026-01-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Week 12
Results posted on
2026-01-21
Participant Flow
Unit of analysis: Flanks
Participant milestones
| Measure |
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.
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Overall Study
STARTED
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30 60
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Overall Study
COMPLETED
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30 60
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Overall Study
NOT COMPLETED
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0 0
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Reasons for withdrawal
Withdrawal data not reported
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=30 Participants
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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Age, Continuous
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34.93 years
STANDARD_DEVIATION 4.83 • n=30 Participants
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Sex: Female, Male
Female
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26 Participants
n=30 Participants
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Sex: Female, Male
Male
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4 Participants
n=30 Participants
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PRIMARY outcome
Timeframe: Week 12A 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.
Outcome measures
| Measure |
Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.)
n=30 Participants
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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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
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26 Participants
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SECONDARY outcome
Timeframe: Up to week 12Number of participants with at least one adverse event (AE). AEs were assessed at all visits.
Outcome measures
| Measure |
Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.)
n=30 Participants
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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Safety Assessment by Evaluation of Adverse Events (AEs)
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30 Participants
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SECONDARY outcome
Timeframe: Week 6A 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.
Outcome measures
| Measure |
Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.)
n=30 Participants
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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|---|---|
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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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21 Participants
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SECONDARY outcome
Timeframe: Baseline, Week 6, Week 12Outcome measures
| Measure |
Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.)
n=30 Participants
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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|---|---|
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Change From Baseline in Ultrasonographic Measurement of Dermal and Hypodermal Thickness on Both Flanks at Weeks 6 and 12
Left dermis at baseline
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2.25 mm
Standard Deviation 0.44
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Change From Baseline in Ultrasonographic Measurement of Dermal and Hypodermal Thickness on Both Flanks at Weeks 6 and 12
Left dermis at week 6
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2.44 mm
Standard Deviation 0.48
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Change From Baseline in Ultrasonographic Measurement of Dermal and Hypodermal Thickness on Both Flanks at Weeks 6 and 12
Left dermis at week 12
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2.73 mm
Standard Deviation 0.49
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Change From Baseline in Ultrasonographic Measurement of Dermal and Hypodermal Thickness on Both Flanks at Weeks 6 and 12
Right hypodermis at baseline
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23.70 mm
Standard Deviation 6.35
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Change From Baseline in Ultrasonographic Measurement of Dermal and Hypodermal Thickness on Both Flanks at Weeks 6 and 12
Right dermis at baseline
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2.12 mm
Standard Deviation 0.41
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Change From Baseline in Ultrasonographic Measurement of Dermal and Hypodermal Thickness on Both Flanks at Weeks 6 and 12
Right dermis at week 6
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2.27 mm
Standard Deviation 0.36
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Change From Baseline in Ultrasonographic Measurement of Dermal and Hypodermal Thickness on Both Flanks at Weeks 6 and 12
Right dermis at week 12
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2.44 mm
Standard Deviation 0.42
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Change From Baseline in Ultrasonographic Measurement of Dermal and Hypodermal Thickness on Both Flanks at Weeks 6 and 12
Right hypodermis at week 6
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20.87 mm
Standard Deviation 4.61
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Change From Baseline in Ultrasonographic Measurement of Dermal and Hypodermal Thickness on Both Flanks at Weeks 6 and 12
Right hypodermis at week 12
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20.00 mm
Standard Deviation 3.99
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Change From Baseline in Ultrasonographic Measurement of Dermal and Hypodermal Thickness on Both Flanks at Weeks 6 and 12
Left hypodermis at baseline
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24.68 mm
Standard Deviation 6.43
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Change From Baseline in Ultrasonographic Measurement of Dermal and Hypodermal Thickness on Both Flanks at Weeks 6 and 12
Left hypodermis at week 6
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22.25 mm
Standard Deviation 4.96
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Change From Baseline in Ultrasonographic Measurement of Dermal and Hypodermal Thickness on Both Flanks at Weeks 6 and 12
Left hypodermis at week 12
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20.69 mm
Standard Deviation 4.46
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SECONDARY outcome
Timeframe: Baseline, Week 6, Week 12Outcome measures
| Measure |
Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.)
n=30 Participants
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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|---|---|
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Changes From Baseline in the Bodyweight (Kg) at Weeks 6 and 12
Baseline
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68.57 Kg
Standard Deviation 9.32
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Changes From Baseline in the Bodyweight (Kg) at Weeks 6 and 12
Week 6
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68.90 Kg
Standard Deviation 9.49
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Changes From Baseline in the Bodyweight (Kg) at Weeks 6 and 12
Week 12
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69.13 Kg
Standard Deviation 9.24
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SECONDARY outcome
Timeframe: Baseline, Week 6, Week 12Outcome measures
| Measure |
Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.)
n=30 Participants
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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Changes From Baseline in Right and Left Thigh Circumference at Weeks 6 and 12 Using a Flexible Tape Measure
Left thigh at week 12
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59.35 cm
Standard Deviation 3.75
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Changes From Baseline in Right and Left Thigh Circumference at Weeks 6 and 12 Using a Flexible Tape Measure
Right thigh at baseline
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59.98 cm
Standard Deviation 3.65
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Changes From Baseline in Right and Left Thigh Circumference at Weeks 6 and 12 Using a Flexible Tape Measure
Right thigh at week 6
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59.82 cm
Standard Deviation 3.87
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Changes From Baseline in Right and Left Thigh Circumference at Weeks 6 and 12 Using a Flexible Tape Measure
Right thigh at week 12
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60.23 cm
Standard Deviation 3.37
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Changes From Baseline in Right and Left Thigh Circumference at Weeks 6 and 12 Using a Flexible Tape Measure
Left thigh at baseline
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59.50 cm
Standard Deviation 3.74
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Changes From Baseline in Right and Left Thigh Circumference at Weeks 6 and 12 Using a Flexible Tape Measure
Left thigh at week 6
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59.03 cm
Standard Deviation 3.82
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SECONDARY outcome
Timeframe: Baseline, Week 6, Week 12Outcome measures
| Measure |
Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.)
n=30 Participants
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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|---|---|
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Changes From Baseline in Caliper Measurement (mm) of Flank Fat on Each Side at Weeks 6 and 12
Right caliper at baseline
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4.89 mm
Standard Deviation 0.58
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Changes From Baseline in Caliper Measurement (mm) of Flank Fat on Each Side at Weeks 6 and 12
Right caliper at week 6
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4.52 mm
Standard Deviation 0.62
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Changes From Baseline in Caliper Measurement (mm) of Flank Fat on Each Side at Weeks 6 and 12
Right caliper at week 12
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4.16 mm
Standard Deviation 0.59
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Changes From Baseline in Caliper Measurement (mm) of Flank Fat on Each Side at Weeks 6 and 12
Left caliper at baseline
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4.76 mm
Standard Deviation 0.59
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Changes From Baseline in Caliper Measurement (mm) of Flank Fat on Each Side at Weeks 6 and 12
Left caliper at week 6
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4.43 mm
Standard Deviation 0.60
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Changes From Baseline in Caliper Measurement (mm) of Flank Fat on Each Side at Weeks 6 and 12
Left caliper at week 12
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4.03 mm
Standard Deviation 0.56
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SECONDARY outcome
Timeframe: Baseline, Week 6, Week 12Outcome measures
| Measure |
Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.)
n=30 Participants
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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Changes From Baseline in Waist Circumference at Weeks 6 and 12 Using a Flexible Tape Measure
Baseline
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91.83 cm
Standard Deviation 6.66
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Changes From Baseline in Waist Circumference at Weeks 6 and 12 Using a Flexible Tape Measure
week 6
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90.72 cm
Standard Deviation 6.31
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Changes From Baseline in Waist Circumference at Weeks 6 and 12 Using a Flexible Tape Measure
week 12
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88.98 cm
Standard Deviation 6.20
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SECONDARY outcome
Timeframe: Week 6, Week 12A 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).
Outcome measures
| Measure |
Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.)
n=30 Participants
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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|---|---|
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Subject's Satisfaction at Weeks 6 and 12 Using a 10-point Likert Scale
week 6
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7.0 score on a scale
Interval 6.0 to 8.0
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Subject's Satisfaction at Weeks 6 and 12 Using a 10-point Likert Scale
week 12
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7.5 score on a scale
Interval 5.0 to 9.0
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Adverse Events
Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.)
Serious events: 0 serious events
Other events: 30 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=30 participants at risk
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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General disorders
Injection site bruising
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86.7%
26/30 • Baseline, Week 6, Week 12
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General disorders
Injection site pain
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70.0%
21/30 • Baseline, Week 6, Week 12
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General disorders
Injection site swelling
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33.3%
10/30 • Baseline, Week 6, Week 12
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General disorders
Injection site pruritus
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26.7%
8/30 • Baseline, Week 6, Week 12
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General disorders
Injection site necrosis
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3.3%
1/30 • Baseline, Week 6, Week 12
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General disorders
injection site urticaria
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3.3%
1/30 • Baseline, Week 6, Week 12
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General disorders
injection site skin tightness
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3.3%
1/30 • Baseline, Week 6, Week 12
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place