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

 
1
 
 
 
Evaluating the efficacy and safety of Embella® (Deoxycholic acid, produced by Espad 
Pharmed Darou Company) for the treatment of flank fat 
 
Protocol Revision Number: 1.1 
Date: 24/01/2024 
 
Confidential 
The information contained in this document is the property of Espad Pharmed Darou 
Company. The contents of this document must not be disclosed, except to study investigators, 
responsible personnel, regulatory authorities, and the ethics committee, without written 
permission from Espad Pharmed Darou Company, unless required to the extent necessary for 
obtaining informed consent from individuals who may potentially be prescribed the product. 
 
 

 
2
 
 
Table of contents 
1 
Confidential Information ............................................................................................................................... 3 
2 
Abbreviations ................................................................................................................................................. 4 
3 
General Information (Administrative Information) ....................................................................................... 5 
3.1 
Scientific Title of the Study .................................................................................................................. 5 
3.2 
Study Registration ................................................................................................................................. 5 
3.3 
Date and Revision Number of the Protocol ........................................................................................... 5 
3.4 
Specifications, Roles, and Responsibilities ........................................................................................... 6 
3.5 
Introduction and Statement of the Problem ........................................................................................... 9 
4 
Study Objectives and Hypotheses ................................................................................................................ 11 
4.1 
Study Hypothesis: ............................................................................................................................... 11 
4.2 
Primary Objective: .............................................................................................................................. 11 
4.3 
Secondary Objectives: ......................................................................................................................... 11 
5 
Study Design and Methodology ................................................................................................................... 12 
5.1 
Study Population: ................................................................................................................................ 12 
5.2 
Study Outcomes and Methods of Assessment: ................................................................................... 15 
Primary Outcome ......................................................................................................................................... 15 
Secondary Outcome(s) ................................................................................................................................. 15 
5.3 
Study Schedule Table .......................................................................................................................... 16 
6 
Sample Size Calculation Method ................................................................................................................. 17 
6.1 
Statistical Analysis .............................................................................................................................. 17 
7 
Harms ........................................................................................................................................................... 17 
8 
Ethical Considerations and Dissemination of Results.................................................................................. 18 
8.1 
Ethics Committee Approval ................................................................................................................ 18 
8.2 
Informed Consent Form ...................................................................................................................... 19 
8.3 
Method of Results Dissemination ....................................................................................................... 19 
9 
References .................................................................................................................................................... 20 
 
 
 
 
 

 
3
 
 
1 
Confidential Information 
Confidential information contained in this current document is provided to you, as the 
investigator and sponsor, for your review, as well as for review by your colleagues and the 
Ethics Committee (IRB/IEC). By accepting this document, you agree that the information 
contained herein will not be disclosed to others without written permission from Espad 
Pharmed Darou Company and the principal investigator of the study, except to the extent 
necessary for obtaining informed consent from individuals to whom the product will be 
administered. By signing the section below, the investigator commits to adhering to the 
specified terms of the protocol and also undertakes that any changes to the protocol must be 
approved by Espad Pharmed Darou Company prior to obtaining approval from the Ethics 
Committee. 
 
Principal Investigator: 
Name and Surname: Dr. Kamran Balighi 
Position: Faculty Member at Tehran University of Medical Sciences and Health Services 
Stamp and Signature: 
Date: ........./........./......... 
 
Sponsor Representative: 
Name and Surname: Dr. Hamidreza Kafi 
Position: Medical Unit Director of Orchid Pharmed Company, representing Espad Pharmed 
Darou Company 
Signature: 
Date: ........./........./.......... 
 
 
 
 
 

 
4
 
 
2 
Abbreviations 
ADR 
Adverse Drug Reaction 
AE 
Adverse Event 
ANOVA 
Analysis of Variance 
ASIS 
Anterior Superior Iliac Spine 
BMI 
Body Mass Index 
CD36 
Cluster of Differentiation 36 
CRP 
C-reactive protein 
FDA 
Food and Drug Administration 
GAIS 
Global Aesthetic Improvement Scale 
GCP 
Good Clinical Practice 
HIV 
Human Immunodeficiency Virus 
ICF 
Informed Consent Form 
IQR 
Interquartile Range 
IRCT 
Iranian Registry of Clinical Trials 
MedDRA 
Medical Dictionary for Regulatory Activities 
MRI 
Magnetic Resonance Imaging 
PT 
Preferred Term 
SAE 
Serious Adverse Event 
SD 
Standard Deviation 
 
 

 
5
 
 
3 
General Information (Administrative Information) 
3.1 
Scientific Title of the Study 
Evaluating the efficacy and safety of Embella (Deoxycholic acid, produced by Espad Pharmed 
Darou Company) for the treatment of flank fat  
3.2 
Study Registration 
• 
Ethics Code: 
o Name of University of Medical Sciences/Name of Institution: Tehran University of 
Medical Sciences   
Code: IR.TUMS.MEDICINE.REC.1402.700   
Date:  04/03/2024 
• 
Study Registration Code in the Iranian Registry of Clinical Trials (IRCT): 
IRCT20240416061507N1 
 
3.3 
Date and Revision Number of the Protocol 
Protocol Revision Number: 1.1 
Date: 23/08/2025 
 
 

 
6
 
 
3.4 
Specifications, Roles, and Responsibilities 
Sponsor: Espad Pharmed Darou Company 
Contact Address: Espad Pharmed Darou Company, Third Floor, No. 56, Azimi Street, Nafisi 
Street, Ekbatan, Tehran, Iran 
Telephone: +98 21 4463 1124 
Email: info@espadpharmed.com 
 
Sponsor Representative: 
Name and Surname: Dr. Hamidreza Kafi, Medical Unit Director of Orchid Pharmed 
Company, representing Espad Pharmed Darou Company 
Contact Address: Orchid Pharmed Company, No. 42, Attar Square, Attar Street, Valiasr 
Street, Vanak Square, Tehran, Iran 
Telephone: +98 21 4347 3000, Ext. 4400 
Stamp and Signature: 
 
 
Roles and Responsibilities: 
✓ Preparation of the Final Draft of the Protocol 
✓ Development of Study Booklet Forms 
✓ Obtaining the necessary permits from foreign organizations for conducting the study 
✓ Provision of the protocol and other necessary training courses for the medical center 
staff 
✓ Provision of study-related expenses for participants, if necessary. 
✓ Assessment of the facility’s capabilities for implementation and continuation of the 
study, and undertaking necessary measures to provide them (ensuring an adequate 
number of consent forms and other materials required for the execution of the study) 
✓ Review of Booklet Forms 
✓ Preparation of a Report on Cases of Non-Conformity and Site Requirements, and 
Submission to Company Management 
✓ Non-disclosure of the information contained in the protocol and study data without 
written permission from the principal investigator of the study 
✓ Provision of financial support for all activities anticipated in the study protocol 
through the establishment of contracts with the investigators. 

 
7
 
 
✓ Analysis and Interpretation of Results 
 
Principal Investigator Information: 
 
Name and Surname: Dr. Kamran Balighi 
Education and Specialty: Dermatology Specialist 
Position: Faculty Member at Tehran University of Medical Sciences and Health Services 
Contact Address: Razi Specialized Dermatology Hospital, Razi Alley, Vahdat Eslami Square, 
Vahdat Eslami Street, Tehran, Iran 
Contact Telephone Number: +98 21 5563 0553 
Email: Kamran.balighi@yahoo.com 
Stamp and Signature: 
Date: ........./........./......... 
 
Roles and Responsibilities: 
− Conducting the study in accordance with the protocol approved by the Ethics 
Committee 
− Establishment of a Team for Conducting the Study 
− Holding training sessions for new and current team members whenever necessary 
− Approval and supervision of the appropriate site for product storage 
− Approval and Supervision of an Appropriate Site for Candidate Admission 
− Non-disclosure of the information contained in the protocol and study data without 
written permission from Espad Pharmed Darou Company (except to the extent 
necessary for obtaining informed consent from individuals for whom the product will 
be prescribed). 
 
Details of the Participants Recruitment Center and Principal Investigators at Each Center: 
 
1. Name and Surname: Dr. Kamran Balighi 
Position: Faculty Member and Professor at Tehran University of Medical Sciences and 
Health Services 
Education and Specialty: Dermatology Specialist 

 
8
 
 
Patient Admission Center: Razi Specialized Dermatology Hospital 
Workplace Address: Razi Specialized Dermatology Hospital, Razi Alley, Vahdat Eslami 
Square, Vahdat Eslami Street, Tehran, Iran  
Contact Phone Number: +98 21 5563 0553 
2. Name and Surname: Dr. Navid Namaki Zadeh Esfahani 
Position: Doctor of Medicine (MD) 
Education and Specialty: Doctor of Medicine (MD) 
Patient Recruitment Center: Razi Specialized Dermatology Hospital 
Workplace Address: Razi Specialized Dermatology Hospital, Razi Alley, Vahdat Eslami 
Square, Vahdat Eslami Street, Tehran, Iran 
Contact Phone Number: +98 21 5563 0553 
 
Roles and Responsibilities: 
− Conducting the study in accordance with the protocol approved by the principal 
investigator and ethics committees. 
− Establishment of a Team for Conducting the Study at the Participants Recruitment Site 
− Non-disclosure of the information contained in the protocol and study data without 
written permission from Espad Pharmed Darou Company and the principal investigator 
of the study (except to the extent necessary for obtaining informed consent from 
individuals for whom the product will be prescribed). 
− Holding training and practice sessions for new and current team members whenever 
necessary 
− Preparation of an Appropriate Site for Participants Admission 
− Preparation of an appropriate location for the storage of products used in the study 
Principal Investigators’ Details at the Center: 
• 
Razi Specialized Dermatology Hospital 
Contact Address: Razi Specialized Dermatology Hospital, Razi Alley, Vahdat Eslami 
Square, Vahdat Eslami Street, Tehran, Iran 
Telephone: +98 21 5288 8282 
- Collaborating investigators at this site who are involved in patient recruitment and 
performing the duties of a "collaborating investigator": 
1- Dr. Kamran Balighi – Faculty Member and Professor at Tehran University of Medical 
Sciences and Health Services 
2- Dr. Namakizadeh – Doctor of Medicine (M.D.) 
 
 

 
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3.5 
Introduction 
With the increasing demand for body contouring, non-invasive or minimally invasive methods 
for reducing localized fat in various areas of the body have gained growing popularity over the 
past decade (1). Localized adipose deposits are typically found in regions such as the abdomen, 
flanks, thighs, inner knee, arms, and others. Although diet, exercise, and bariatric surgery may 
be effective in controlling obesity, aesthetic procedures remain necessary for the removal or 
reduction of localized fat deposits in areas resistant to these interventions, such as the flanks 
and abdomen. Liposuction is the most common method for reducing excess localized fat; 
however, as an invasive surgical technique, it is associated with complications such as pain, 
infection, prolonged recovery, scarring, hematoma, deep vein thrombosis, pulmonary 
embolism, and anesthesia-related adverse effects. These complications, along with the 
extended recovery period, have led patients to seek alternative, less invasive methods for body 
contouring. Currently, non-invasive fat reduction techniques include low-level lasers, 
radiofrequency, ultrasound, infrared light, cryolipolysis, and the use of injectable solutions 
containing fat-dissolving agents. Treatments that are minimally invasive and not accompanied 
by the aforementioned complications are ideal for patients seeking reduction of localized fat 
for body contouring (2). 
Multiple clinical trial studies have been reported in the field of adipose tissue reduction through 
subcutaneous injection of solutions containing phosphatidylcholine and bile salts, specifically 
sodium deoxycholate, and consequently, these treatments have gained significant popularity. 
Studies have demonstrated that deoxycholate is the primary active ingredient in the 
aforementioned injectable solutions and is responsible for the clinical reduction of adipose 
tissue (3). 
Synthetic purified deoxycholic acid has been introduced as the first pharmacological 
intervention approved by the FDA for the reduction of submental fat. Deoxycholic acid is a 
type of bile acid which, due to its ability to induce non-selective cell lysis and disruption of 
adipocyte membranes (adipocytolysis), leads to the emulsification of fat in the intestine (4,5). 
Deoxycholic acid has been used for the reduction of localized fat for three decades. Its 
mechanism of action involves the emulsification of phospholipids and subsequent dissolution 
of biological membranes, which leads to adipocyte necrosis. In a prospective study conducted 
in 2017, the efficacy and safety of a 1.25% sodium deoxycholate solution were evaluated in 
221 patients with various forms and degrees of localized fat. Injections were administered into 
the adipose tissue at 6-week intervals and continued until clinical results were achieved. 

 
10
 
 
Outcomes were assessed using before-and-after photographs and patient satisfaction was 
measured by completion of an anonymous form, while adverse events (AEs) were reported by 
the treating physician. Among 185 patients eligible for final evaluation, the mean treatment 
efficacy score reported by patients was 7.4, and medical assessment indicated treatment success 
in 93.5% of cases. AEs were mainly mild and localized at the injection site, with the incidence 
of severe complications being very rare. The results of this study confirm the efficacy and 
safety of deoxycholic acid injections for the reduction of localized fat (6). 
In another study, the efficacy and safety of deoxycholic acid injection in the abdominal area 
were evaluated in 7 female patients. The results indicate that its mechanism of action is through 
the increase of crown-like structures and macrophage infiltration, as well as the reduction of 
leptin expression, hormone-sensitive lipase, triglyceride lipase, and CD36, ultimately resulting 
in adipose tissue necrosis. In the evaluation of systemic inflammatory markers, including CRP, 
lipid profile, and blood glucose, no significant changes were observed (7). 
In another study, with an emphasis on the effect of deoxycholic acid in reducing the volume of 
submental adipose tissue, new sites for its injection were proposed. This study reported that 
deoxycholic acid can be used as an alternative method in areas where other interventions, such 
as liposuction, do not have acceptable efficacy or safety. In this study, smaller areas of fat 
accumulation, such as the axilla, upper arm, and around the knee, were suggested for further 
investigation in future studies. Additionally, the injection of modified concentrations of 
deoxycholic acid in larger areas, such as superficial abdominal fat, may be beneficial (8). 
In a study aimed at reducing local pain and inflammation caused by deoxycholic acid injection, 
a combination of deoxycholic acid with lidocaine and triamcinolone was used. The resulting 
solution was injected at one-centimeter intervals into the medial aspect of the right thigh of one 
patient and the distal regions of both arms of a second patient. Additionally, undiluted 
deoxycholic acid solution was injected as a control into the medial aspect of the left thigh of 
the first patient. The results of the evaluation in two cases indicated that the use of this method 
was effective for larger areas by increasing the spreadability and tolerability, and was 
associated with lower consumption of deoxycholic acid and fewer side effects (9). 
The first successful case report of deoxycholic acid injection for the reduction of flank fat in 
the United States was published in 2018. In this study, a 39-year-old male received deoxycholic 
acid injections with a total volume of 4 cc (2 cc on each side) in the flank fat area. Follow-up 
at 12 weeks demonstrated a gradual reduction of fat in this region, and no recurrence of fat 
accumulation was observed at the 12-month follow-up. The patient was completely satisfied 
with the outcome (10). 

 
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Given that non-invasive methods have subtle effects that are not immediately observable, 
various objective and subjective techniques are utilized to assess their efficacy. In most studies, 
measurement of the circumference of the target area before and after the intervention is reported 
as an indicator. Other objective techniques, such as the use of calipers, ultrasound, MRI, and 
three-dimensional photography, have also been employed. Common subjective methods 
include the evaluation of standardized photographs by a blinded assessor and patient 
satisfaction surveys. All existing methods for quantifying non-invasive fat reduction have 
significant limitations and cannot be relied upon independently (11). 
4 
Study Objectives and Hypotheses 
4.1 
Study Hypothesis: 
The injectable solution containing deoxycholic acid (Embella, manufactured by Espad 
Pharmed Darou Company) demonstrates appropriate efficacy and safety in the reduction of 
lateral abdominal fat. 
4.2 
Primary Objective: 
The aim of this study is to determine the efficacy and safety of the injectable solution 
containing deoxycholic acid (Embella, manufactured by Espad Pharmed Darou Company) in 
reducing fat in the flank area. 
4.3 
Secondary Objectives: 
• 
The proportion of participants who, at week 6, according to the investigator's 
assessment on the GAIS score, have achieved a score of 1 or higher (improved, much 
improved, or very much improved). 
• 
Changes from baseline in waist circumference at weeks 6 and 12 using a flexible 
measuring tape. 
• 
Changes from baseline in body weight at weeks 6 and 12. 
• 
Changes from baseline in right and left thigh circumference at weeks 6 and 12 using a 
flexible measuring tape. 
• 
Changes from baseline in flank fat on each side measured by caliper at weeks 6 and 
12. 

 
12
 
 
• 
Assessment of the trend in dermal and hypodermal thickness changes on both sides by 
measurement with ultrasonography from baseline to weeks 6 and 12 
• 
Assessment of participants’ satisfaction at weeks 6 and 12 
• 
Assessment of the incidence of AEs following treatment 
5 
Study Design and Methodology 
5.1 
Study Population: 
• Inclusion Criteria: 
1. Men and women aged between 21 and 65 years 
2. Presence of mild to moderate flank fat, as assessed by the investigator and ultrasound 
and/or caliper (with a thickness of ≥2 cm of adipose tissue at the posterior axillary 
lines at the level of the ASIS). 
3. Signing of the informed consent form by the participants 
4. Ability to comply with study instructions and likelihood of completing all required 
visits 
5. Agreement to abstain from any treatment in the flank area, including botulinum toxin, 
hyaluronic acid fillers, cosmetic surgery, laser/light therapy, chemical peels, etc., 
throughout the study period. 
• Exclusion Criteria: 
1. Planning for lifestyle modification during the predicted duration of the study 
2. History of liposuction or laser lipolysis surgery within the past 12 months, or intention 
to undergo these procedures 
3. Significant weight loss in the past 6 months or planned weight loss during the 
anticipated duration of the study 
4. Body mass index (BMI) greater than 30 kg/m2 
5. Waist circumference greater than 105 centimeters 
6. Affliction with uncontrolled systemic diseases 
7. Severe cardiovascular diseases 

 
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8. Known hypersensitivity or allergy to the study product or its components 
9. Pregnant women, breastfeeding women, or women who are expected to become 
pregnant during the anticipated duration of the study 
10. Current enrollment in a drug or investigational device study, or participation in such a 
study within the past 30 days, as well as during the course of the study. 
11. Previous treatment of the flank area with hyaluronic acid fillers or semi-permanent 
fillers within the past 12 months 
12. Use of permanent fillers or silicone in the flank area 
13. Individuals who intend to undergo cosmetic procedures in the treatment area during 
the study, or who have a history of cosmetic procedures (such as surgery) or visible 
scars in that area that may affect the assessment. 
14. Individuals with volume loss due to trauma, adipose tissue disorders associated with 
autoimmune diseases such as generalized lipodystrophy (e.g., in juvenile 
dermatomyositis), localized lipodystrophy (such as Barraquer-Simons syndrome), 
hereditary diseases, or HIV-associated disease 
15. Infection or skin diseases at the injection site 
16. Evidence of recent alcohol or drug abuse 
17. Medical and/or psychiatric conditions of such severity that they may interfere with the 
outcomes of the study 
18. Having a known bleeding disorder or the use of medications that increase the 
likelihood of bleeding after injection 
19. Presence of hair in the flank area that interferes with assessment or treatment 
20. Predisposition to hypertrophic scar formation 
21. History of anaphylaxis or allergy to lidocaine (or other amide anesthetics), hyaluronic 
acid products, or streptococcal proteins 
22. Affliction with Porphyria 
23. Presence of active inflammation, infection, malignant or premalignant lesion, or non-
healed ulcer in the flank region 

 
14
 
 
24. Having a condition or being in a situation which, in the opinion of the investigator, 
may place the individual at significant risk, disrupt the study results, or interfere with 
the individual’s participation in the study. 
• Withdrawal Criteria: 
1. Withdrawal of participant from informed consent 
2. Non-compliance, including refusal to adhere to the medical requirements of the study, 
failure to undergo procedures specified in the study protocol, or use of prohibited 
medications. 
3. Inability to follow up on the participant’s status 
4. Treatment of the flank area with hyaluronic acid fillers or semi-permanent fillers 
during the course of the study 
5. The use of any permanent filler or silicone materials in the flank area during the 
course of the study 
6. Undergoing any cosmetic procedures in the treatment area during the study period 
(such as surgery) 
7. Having conditions that, in the opinion of the investigator, may interfere with the 
assessment of efficacy 
 
 
 

 
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5.2 
Study Outcomes and Methods of Assessment: 
Primary Outcome 
• 
The proportion of participants who, at week 12, according to the investigator’s 
assessment on the GAIS score, have achieved a score of 1 or higher (improved, much 
improved, or very much improved). 
Secondary Outcome(s) 
• 
The proportion of participants who, at week 6 based on the investigator's assessment 
on the GAIS score, have achieved a score of 1 or higher (improved, much improved, 
or very much improved). 
• 
Changes from baseline in waist circumference at weeks 6 and 12 using a flexible 
measuring tape. 
• 
Changes from baseline in body weight at weeks 6 and 12. 
• 
Changes from baseline in right and left thigh circumference at weeks 6 and 12 using a 
flexible measuring tape. 
• 
Changes from baseline in flank fat on each side measured by caliper at weeks 6 and 
12. 
• 
Assessment of the trend in dermal and hypodermal thickness changes on both sides by 
measurement with ultrasonography from baseline to weeks 6 and 12 
• 
Assessment of participant satisfaction at weeks 6 and 12 
• 
Assessment of the incidence of AEs following treatment 
 
 

 
16
 
 
5.3 
Study Schedule Table 
Study Duration  
Screening Intervention Follow-up 
Time Point 
Screening 
Visit 
Visit 1 
Visit 2 Visit 3 
Time 
Day -7 to 
-1 
Day 0 
Week 
6 ± 1 
week 
Week 
12 ± 1 
week 
Informed Consent 
Form 
× 
Assessment of 
Inclusion and 
Exclusion Criteria 
× 
Medical History 
× 
Physical Examination 
and Vital Signs 
  
× 
× 
  
Concomitant 
Medications 
× 
× 
× 
× 
Skin Ultrasonography 
× 
× 
× 
Photography 
 
×* 
× 
× 
Intervention 
  
× 
×** 
  
GAIS Assessment 
× 
× 
Assessment of 
Participant Satisfaction 
× 
Adverse Event 
Assessment 
× 
× 
× 
× 
 
 
* Photography must be performed prior to injection. 
** In case a touch-up injection is deemed necessary by the physician. 
 

 
 
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6 
Sample Size Calculation Method 
In this study, 30 participants will be enrolled. 
6.1 
Statistical Analysis 
Study Profile 
All participants who sign the informed consent form will be included in the final statistical 
report. The participants flow throughout the study, reasons for withdrawal from the study, 
and major deviations and violations of the protocol will be reported. 
Primary Endpoint Analysis 
Participants who, in the GAIS score assessment by the investigator, received a score of 1 or 
higher will be reported with the number and percentage. 
Secondary Endpoint Analysis 
Descriptive analysis of data for quantitative variables will be reported as mean and standard 
deviation (SD) or median and interquartile range (IQR), based on the data distribution, and 
for qualitative variables as the number and percentage. Changes over time will be analyzed 
using repeated measures analysis of variance (repeated measures ANOVA) or the Friedman 
test, depending on the data distribution. Comparisons between baseline and subsequent 
timepoints will also be performed using the paired t-test or the Wilcoxon test, as appropriate. 
The significance level for the tests will be considered as 0.05. 
 
Adverse Events’ Analysis 
AEs will be classified according to the MedDRA dictionary based on the Preferred Term 
(PT) and analyzed in terms of frequency and percentage. The severity and seriousness of each 
event will also be reported. 
7 
Harms 
Adverse Events 
An AE is described as any occurrence that happens to a participant in the study and presents 
with clinical manifestations differing from the progression of baseline conditions. It does not 
necessarily have a causal relationship with the investigational treatment used in the study. 

 
 
18
 
 
Clinical manifestations that will be reported as AEs include any symptom, sign (such as an 
abnormal laboratory result), or temporary illness associated with the use of the investigational 
product, regardless of whether a causal relationship with the product is suspected or not. 
An adverse drug reaction (ADR) is described as a harmful response to a drug that occurs at 
doses normally used in humans for the prevention, diagnosis and treatment of diseases, or 
modification of a physiological function. 
Classification of AEs Based on Severity 
The severity of AEs is classified by the physician’s assessment as mild, moderate, or severe. 
Classification of AEs Based on Seriousness 
An event is considered a serious adverse event (SAE) if: 
• 
Results in death. 
• 
Is life-threatening or results in a risk of death. 
• 
Requires inpatient hospitalization or prolongation of existing hospitalization.  
• 
Results in persistent or significant disability/incapacity. 
• 
Is a congenital anomaly/birth defect. 
• 
Results in a condition requiring special clinical intervention for the participant. 
Adverse Event Reporting 
All AEs, including both serious and non-serious AEs that occur following administration of 
the product, shall be precisely documented. The description of the event, its chronological 
sequence relative to the time of product administration, its duration, the processes utilized for 
its diagnosis, and the outcomes of any re-exposure to the product must be recorded. 
Furthermore, a qualitative assessment of the AE, conducted by the investigator based on its 
severity and its relationship to the administered product, must also be documented. 
8 
Ethical Considerations and Dissemination of Results 
8.1 
Ethics Committee Approval 
- 
Ethics committee approval is mandatory prior to the initiation of this study. 
- 
No participants will be enrolled in the study without providing informed consent. 
- 
All participants will be informed that they may withdraw from the study at any time and 
without providing any explanation, should they so wish. 
- 
AE report forms will be evaluated during the study. The study research team is 
responsible for the prompt review of any AE that occur (regardless of whether the event 
is directly attributable to the investigational drug or not). 
 
 
 

 
 
19
 
 
8.2 
Informed Consent Form 
During the screening of participants for study enrollment and prior to any procedures, the 
investigator shall fully explain the purpose and details of the study to the participants in clear 
and simple language. After answering any potential questions, sufficient time and opportunity 
will be provided to the participants to inquire about the study details so that they can decide 
whether or not to participate in the study. Additionally, the study investigator will explain to 
the participants that they are free to refuse the use of their information or to withdraw from 
the study at any time and for any reason. 
When the information provided to the participants has been understood by them and the 
requested explanations have been given to the participants, the participants is given sufficient 
time to sign the informed consent form and to write their first and last name on the consent 
form. The investigator physician shall also stamp and sign the relevant consent form. For 
each participants, two copies of the consent form, stamped and signed by both the physician 
and the participants, are prepared; one copy is given to the participants and the other copy 
remains at the site and with the investigator. The investigator and the study sponsor may, at 
any time and for operational reasons, withdraw the participants from the study. Any other 
necessary information to fully protect the human rights of the participants, in accordance with 
GCP guidelines, local and national regulations for conducting clinical studies, and the 
Declaration of Helsinki, will also be explained. 
 
8.3 
Method of Results Dissemination 
Any dissemination of results prior to the initial publication shall be unauthorized. Any 
subsequent presentation or publication of results (including sub-studies) by any member of 
the study team must be approved by the principal investigator and the sponsor, and reference 
must be made to the study and the initial publication of the data. The final decision regarding 
the publication of any version/summary/presentation will be made by the principal 
investigator of the study and the sponsor. 
 
 
 
 
 

 
 
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9 
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1.  Ultrasound HF, Saedi N, Kaminer M. New Waves for Fat Reduction : 2013;26–30. 
2.  Garibyan L, Sipprell WH, Jalian HR, Sakamoto FH, Avram M, Anderson RR. Three-
dimensional volumetric quantification of fat loss following cryolipolysis. Lasers Surg Med. 
2014;46(2):75–80. 
3.  Rotunda AM, Ablon G, Kolodney MS. Lipomas treated with subcutaneous deoxycholate 
injections. J Am Acad Dermatol. 2005;53(6):973–8. 
4.  Dunican KC, Patel DK. Deoxycholic Acid (ATX-101) for Reduction of Submental Fat. Ann 
Pharmacother. 2016;50(10):855–61. 
5.  Shome D, Khare S, Kapoor R. The Use of Deoxycholic Acid for the Clinical Reduction of 
Excess Submental Fat in Indian Patients. J Drugs Dermatology. 2019;18(3):266–72. 
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effectiveness of an injectable solution acid deoxycholic based for reduction of localized 
adiposities. Plast Reconstr Surg - Glob Open. 2018;6(6):1–5. 
7.  Reeds DN, Mohammed BS, Klein S, Boswell CB, Young VL. Metabolic and structural 
effects of phosphatidylcholine and deoxycholate injections on subcutaneous fat: A randomized, 
controlled trial. Aesthetic Surg J. 2013;33(3):400–8. 
8.  Sykes JM, Allak A, Klink B. Future applications of deoxycholic acid in body contouring. J 
Drugs Dermatology. 2017;16(1):43–6. 
9.  Nathan NR, Pollock SE, Kourosh AS. A novel protocol for the use of deoxycholic acid in 
body contouring mitigating pain and inflammation while maintaining efficacy: Piloted on 
different body sites. Int J Women’s Dermatology [Internet]. 2020;6(3):233–4. Available from: 
https://doi.org/10.1016/j.ijwd.2020.03.031 
10.  Jegasothy BYSM. Deoxycholate injection lipolysis of flank fat in a healthy male patient. 
2018;(June):42–4. 
11.  Auh SL, Iyengar S, Weil A, Bolotin D, Cartee T V., Dover JS, et al. Quantification of 
noninvasive fat reduction: A systematic review. Lasers Surg Med. 2018;50(2):96–110.