Evaluating the Efficacy and Safety of Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) for the Treatment of Flank Fat

NCT07004010 | Completed Results

• 1 other identifier: EMB.ESP.KB.IV.02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Flank Fat

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Safety Assessment by Evaluation of Adverse Events (AEs)

  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

  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

Study Arms (1)

Embella (Deoxycholic acid, produced by Espad Pharmed Co.)

EXPERIMENTAL

Device: Deoxycholic Acid Injection

Interventions

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)

Embella (Deoxycholic acid, produced by Espad Pharmed Co.)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having mild to moderate flank fat assessed by the investigator and sonography and/or caliper (≥2cm thickness of the fat tissue in posterior axillary lines at the level of ASIS)
• Signing informed consent by the subject
• Ability to follow study instructions and likely to complete all required visits
• Agreement to abstain from any treatment to the flank region, including botulinum toxins, hyaluronic acid fillers, cosmetic surgery, laser/light therapy, chemical peels, etc., during the study

You may not qualify if:

• Planning to change lifestyle within the projected duration of the trial
• History of liposuction surgery or laser lipolysis in the past 12 months or planning to have these procedures
• Significant weight reduction in the past 6 months or planning for weight reduction within the projected duration of the trial
• BMI \> 30 kg/m2
• Waist circumference \> 105 cm
• Uncontrolled systemic diseases
• Severe cardiovascular diseases
• Known allergy or sensitivity to the study medication or its components
• Females who are pregnant or breastfeeding, or expecting to conceive children within the projected duration of the trial
• Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study and for the duration of the study.
• Previous treatment to the flanks with hyaluronic acid fillers or semi-permanent filler in the past 12 months
• Use of any permanent filler materials or silicone in the flanks
• Subjects planning a cosmetic procedure in the treatment area during the study or with prior cosmetic procedures (i.e., surgery) in the treatment area or visible scars that may affect the evaluation
• Subjects with volume deficit due to trauma, abnormalities in adipose tissue related to immune-mediated diseases such as generalized lipodystrophy (e.g., juvenile dermatomyositis), partial lipodystrophy (e.g., Barraquer-Simons syndrome), inherited disease, or HIV-related disease
• Infection or dermatoses at the injection site

Sponsors & Collaborators

• Espad Pharmed: lead

Study Sites (1)

Razi hospital

Tehran, 11996-63911, Iran

Location

Results Point of Contact

• Title: Hamidreza Kafi
• Organization: EspadPharmed

Kafi.h@orchidpharmed.com

989129232594

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: before/after clinical trial

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 4, 2025
• Study Start: August 1, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: January 21, 2026
• Results First Posted: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)