Flank FatNCT07004010
Evaluating the Efficacy and Safety of Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) for the Treatment of Flank Fat
A study testing Deoxycholic Acid Injection in people with Flank Fat, run by Espad Pharmed at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Flank Fat
- What is being tested?
- Deoxycholic Acid Injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- 1 Aug 2024to 30 Dec 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
- Evidence of recent alcohol or drug abuse
- Medical and/or psychiatric problems that are severe enough to interfere with the study results
- Known bleeding disorder or receiving medication that will likely increase the risk of bleeding after injection
- Having hair that would interfere with evaluation and treatment of the flank area
- Being prone to develop hypertrophic scarring
- Having a history of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), hyaluronic acid products, or Streptococcal protein
- Having porphyria
- Having an active inflammation, infection, cancerous or precancerous lesion, or unhealed wound in the flank area
- Having a condition or being in a situation that, in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Deoxycholic Acid Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deoxycholic Acid InjectionDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| Embella (Deoxycholic acid, produced by Espad Pharmed Co.) | Experimental | Not described Receives: Device: Deoxycholic Acid Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 12
Secondary outcomes (8)
Safety Assessment by Evaluation of Adverse Events (AEs)
Number of participants with at least one adverse event (AE). AEs were assessed at all visits.
Measured: 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
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.
Measured: Week 6
Change From Baseline in Ultrasonographic Measurement of Dermal and Hypodermal Thickness on Both Flanks at Weeks 6 and 12
Measured: Baseline, Week 6, Week 12
Changes From Baseline in the Bodyweight (Kg) at Weeks 6 and 12
Measured: Baseline, Week 6, Week 12
Changes From Baseline in Right and Left Thigh Circumference at Weeks 6 and 12 Using a Flexible Tape Measure
Measured: Baseline, Week 6, Week 12
Changes From Baseline in Caliper Measurement (mm) of Flank Fat on Each Side at Weeks 6 and 12
Measured: Baseline, Week 6, Week 12
Changes From Baseline in Waist Circumference at Weeks 6 and 12 Using a Flexible Tape Measure
Measured: 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).
Measured: Week 6, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start1 Aug 2024
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Flank FatStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- before/after clinical trial
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Espad Pharmed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004010
- Sponsor's protocol ID
- EMB.ESP.KB.IV.02
- Status last verified
- Jan 2026
- First submitted
- 27 May 2025
- Last updated
- 21 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No