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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Show all 24Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy and Safety of Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) for the Treatment of Flank Fat
- ClinicalTrials.gov ID
- NCT07004010
- Acronym / sponsor ID
- EMB.ESP.KB.IV.02
- Conditions
- Flank Fat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Espad PharmedIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 4 Jun 2025 (actual)
- Results
- Posted 21 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- before/after clinical trial
| Arm | Type | Receives |
|---|---|---|
| Embella (Deoxycholic acid, produced by Espad Pharmed Co.) | Experimental | Device: Deoxycholic Acid Injection |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deoxycholic Acid InjectionThe 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) | Device | Embella (Deoxycholic acid, produced by Espad Pharmed Co.) |
Primary outcome
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
Time frame: 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.
8 secondary outcomes
Safety Assessment by Evaluation of Adverse Events (AEs)
Time frame: 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
Time frame: Week 6
Change From Baseline in Ultrasonographic Measurement of Dermal and Hypodermal Thickness on Both Flanks at Weeks 6 and 12
Time frame: Baseline, Week 6, Week 12
Changes From Baseline in the Bodyweight (Kg) at Weeks 6 and 12
Time frame: Baseline, Week 6, Week 12
Changes From Baseline in Right and Left Thigh Circumference at Weeks 6 and 12 Using a Flexible Tape Measure
Time frame: Baseline, Week 6, Week 12
Changes From Baseline in Caliper Measurement (mm) of Flank Fat on Each Side at Weeks 6 and 12
Time frame: Baseline, Week 6, Week 12
Changes From Baseline in Waist Circumference at Weeks 6 and 12 Using a Flexible Tape Measure
Time frame: Baseline, Week 6, Week 12
Subject's Satisfaction at Weeks 6 and 12 Using a 10-point Likert Scale
Time frame: Week 6, Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Flank Fat
Recruiting
Clinical Evaluation of Linear Z for Body Contouring
Non Invasive Body Contouring
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deoxycholic Acid Injection in people with Flank Fat, run by Espad Pharmed at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.