Evaluation of safety and effectiveness of an injectable solution containing deoxycholic acid with the brand name ®Embella, in order to reduce submental fat.
Evaluation of safety and effectiveness of an injectable solution containing deoxycholic acid with the brand name ®Embella, in order to reduce submental fat.
Design
Single group, phase 2, before -after clinical study. sample size is 20.
Settings and conduct
The study will be performed in Center for the Study and Research of Diseases of the Skin and Leprosy, 20 volunteers with unwanted submental fat with moderate to severe intensity will be selected and enrolled in the study after signing consent form. Participants will be treated for one to three Injection sessions with ®Embella solution. Before intervention, 4 and 12 weeks after last injection changes in submental fat, diameter of submental area and satisfaction of participants will be measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Ages 18 to 65, People with unwanted submental fat with moderate to severe intensity, grades 2 and 3 of the clinical grade of SMF (submental fat) evaluation, have signed the informed consent form and agree to a 3-month follow-up.
Exclusion criteria:
Any previous intervention to treat submental fat, Specific anatomical features or previous damage to the intervention site (ulcers, liposuction, difficulty swallowing, enlargement of the thyroid gland or lymph nodes) that interfere with the evaluation of intervention results, History of dysphagia.
Intervention groups
Intervention group: At least one and maximum of 3 sessions of treatment with 2 ml of Embella® injectable solution contains 20 mg deoxycholic acid with a minimum interval of 4 weeks.
Main outcome variables
Grading changes in submental fat
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190210042676N29
Registration date:2023-02-14, 1401/11/25
Registration timing:prospective
Last update:2023-02-14, 1401/11/25
Update count:0
Registration date
2023-02-14, 1401/11/25
Registrant information
Name
Aniseh Samadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 2220
Email address
a_samadi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of safety and effectiveness of an injectable solution containing deoxycholic acid with the brand name ®Embella, in order to reduce submental fat.
Public title
Evaluation of an injectable solution with the brand name ®Embella in order to reduce submental fat.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages 18 to 65
People with unwanted submental fat with moderate to severe intensity, grades 2 and 3 of the clinical grade of SMF (submental fat) evaluation
Have signed the informed consent form and agree to a 3-month follow-up.
Exclusion criteria:
Any previous intervention to treat submental fat.
Specific anatomical features or previous damage to the intervention site (ulcers, liposuction, difficulty swallowing, enlargement of the thyroid gland or lymph nodes) that interfere with the evaluation of intervention results.
History of dysphagia
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
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
Ethics committee of The Institute of Pharmaceutical Sciences of Tehran University of Medical Science
Street address
Unit 1-219, 2nd floor,The Institute of Pharmaceutical Sciences, Faculty of Pharmacy,16 Azar Avenue
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2023-01-17, 1401/10/27
Ethics committee reference number
IR.TUMS.TIPS.REC.1401.102
Health conditions studied
1
Description of health condition studied
Submental fat
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Grading changes in submental fat
Timepoint
Before intervention, 4 and 2 weeks after last injection
Method of measurement
Standard grading evaluation of submental fat (SMF)
Secondary outcomes
1
Description
Change in fat diameter of submental area.
Timepoint
Before intervention, 4 and 2 weeks after last injection
Method of measurement
Caliper
2
Description
Consumer Satisfaction
Timepoint
Before intervention, 4 and 2 weeks after last injection
Method of measurement
Using the Likert scale includes: 0 = not satisfied at all, 1 = slightly satisfied, 2 = moderately satisfied, and 3 = very or extremely satisfied
Intervention groups
1
Description
Intervention group: At least one and maximum of 3 sessions of treatment with 2 ml of Embella® injectable solution contains 20 mg deoxycholic acid with a minimum interval of 4 weeks. The product is 2 ml of sterilization transparent and colorless vials free of visible particles containing 20 mg deoxycholic acid. Other compounds include hyaluronic acid, injectable water, sodium chloride, sodium hydroxide, hydrochloric acid and anhydrous disodium phosphate.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
center for research and training in skin diseases and leprosy