Evaluation of the efficacy and safety of Deoxycholic acid injection (Embella®) in flank fat reduction
Design
Phase 4 clinical trial without a control group on 30 patients, the patients are injected with 0.1-0.15 cc of injectable deoxycholic acid solution with the Embella brand in an area of 1 x 1 cm2. The maximum injection volume is 2 cc per session on each side. Patients are injected with medicine every 6 weeks up to 2 times.
Settings and conduct
Operating room of Razi Hospital
Participants/Inclusion and exclusion criteria
Age between 21-65 years
Mild to moderate flank fat
Ability to complete the study and follow instructions
Informed consent to participate in the study
Consent on not performing any other intervention in the flank area during the study period
Severe medical or psychological conditions that interfere with the study results
History of hypersensitivity to components of the product under study
Pregnancy and breastfeeding
History of previous flank fat treatment
BMI >۳۰
Patients prone to intravascular volume reduction
Evidence of recent alcohol or drug abuse
History of hypertrophic scarring
Intervention groups
In this study, patients aged between 21-65 years with minimal to moderate flank fat (clinically proven and based on caliper measurement (at least 2 cm in caliper measurement and ultrasound criteria)) who have referred to Razi Hospital and and tend to improve their appearance are involved.
Main outcome variables
Adverse event
The seriousness of the adverse event
Number of injection sessions
The number of patients needing touch-up injections
The percentage of reduction in the size of side fat
The percentage of reduction in the size of side fat
Number of patients with reduction by more than one GAIS unit
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240416061507N1
Registration date:2024-07-14, 1403/04/24
Registration timing:prospective
Last update:2024-07-14, 1403/04/24
Update count:0
Registration date
2024-07-14, 1403/04/24
Registrant information
Name
Navid Namakizadeh Esfahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4409 6089
Email address
navidnamakizadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-06, 1403/05/16
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the efficacy and safety of Deoxycholic acid injection (Embella®) in reduction of flank fat
Public title
The efficacy and safety of Deoxycholic acid injection in reduction of flank fat
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mild to moderate flank fat (clinically proven and based on caliper measurements and ultrasound criteria)
Ability to complete the study and follow instructions
Informed consent to participate in the study
Consent on not performing any other intervention in the flank area during the study period
Exclusion criteria:
Severe medical or psychological conditions that interfere with the study results
History of hypersensitivity to components of the product under study
Pregnancy and breastfeeding
History of previous flank fat treatment
BMI >۳۰
Patients prone to intravascular volume reduction
Evidence of recent alcohol or drug abuse
History of bleeding disorders or recent consumption (less than 3 weeks) of thrombolytic drugs, anticoagulants, platelet inhibitors orNSAIDs
History of hypertrophic scarring
Infection, inflammation, dermatosis, unhealed wound, cancer or precancerous lesions at the injection site
Age
From 21 years old to 65 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Medical School - Tehran University of Medical Sciences
Street address
Razi Hospital,Razi Dead End,Vahdat-Islami Square,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1199663911
Approval date
2024-03-04, 1402/12/14
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.700
Health conditions studied
1
Description of health condition studied
Flank fat
ICD-10 code
E65
ICD-10 code description
Localized adiposity
Primary outcomes
1
Description
The percentage of flank fat reduction
Timepoint
The beginning of the study and week 6 and 12
Method of measurement
Using ultrasound and calipers
Secondary outcomes
1
Description
Incidence and seriousness of adverse event
Timepoint
week 6 and 12
Method of measurement
Examination by the medical team with a questionnaire
Intervention groups
1
Description
Intervention group: patients aged 21-65 years with clinically proven mild to moderate flank fat and based on measurement with calipers and ultrasound criteria. Before the intervention, the patients are examined by a radiologist specialist and ultrasound is performed to check and measure the dimensions and volume of localized fat. If the diagnosis is proven and other conditions are met, patients will be included in the study. Also, flank fat diameter will be measured using a flexible caliper. Then, patients undergo injection of 0.1-0.15 cc of 10 mg/mL Deoxycholic Acid solution (brand name Embella, Espad Pharmed) per each area of 1 x 1 cm square. The maximum volume of injection is 2 cc per session on each side, and patients are observed for at least half an hour after injection. Drug injection is repeated every 6 weeks up to 2 times and patients undergo ultrasound and caliber evaluation before each injection. It should be noted that from the second injection session onwards, the side effects questionnaire form is filled in all sessions. If there are any side effects that require the intervention of the project physicians at Razi Hospital, they will respond 24 hours a day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Kamran Balighi
Street address
Razi Hospital,Razi Dead End,Vahdat-Islami Square,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5288 8282
Email
kamran.balighi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Espad Pharmed Co
Full name of responsible person
Nasim Anjidani
Street address
Third floor, Spad Farmed, No. 56, Azimi St., Nafisi St., Ekbatan, Tehran
City
Tehran
Province
Tehran
Postal code
1393833166
Phone
+98 21 4463 1124
Email
info@espadpharmed.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Espad Pharmed Co
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kamran Balighi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Razi Hospital,Razi Dead End,Vahdat-Islami Square,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5288 8282
Email
kamran.balighi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kamran Balighi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Razi Hospital,Razi Dead End,Vahdat-Islami Square,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5288 8282
Email
kamran.balighi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kamran Balighi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Razi Hospital,Razi Dead End,Vahdat-Islami Square,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5288 8282
Email
kamran.balighi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data on the main variable can be shared after de-identifying individuals
When the data will become available and for how long
Beginning of the access period up to one year after the publication of the results
To whom data/document is available
Researchers and industrialists based on the request and also the issuance of permission to access the data by the principal investigator and the sponsoring company of the project
Under which criteria data/document could be used
Use for review articles and use in the clinic
From where data/document is obtainable
Corresponding author
kamran.balighi@yahoo.com
What processes are involved for a request to access data/document
Provide documentation of the reason for the request and follow-up via email after the permission to access the data is issued by the principal investigator and the sponsoring company of the project