Clinical trial NCT06509438: Effectiveness and Safety Evaluation of Embella (Deoxycholic Acid, by Espad Pharmed Co.) in Management of Submental Fat
Official title: Evaluating the Effectiveness and Safety of Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) for the Management of Submental Fat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Submental Fullness
Lead sponsor: Espad Pharmed
Sponsor class: INDUSTRY
First posted: 2024-07-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: before/after clinical trial
Primary purpose: TREATMENT

Brief summary: Submental fat (SMF) is a factor affecting beauty that makes people feel uncomfortable about themselves. In 2015, deoxycholic acid with the brand name KYBELLA® was approved by the American FDA for treatment of submental fat. The purpose of this study is to evaluate the safety and effectiveness of deoxycholic acid injection with the brand name Embella®, manufactured by Espad Pharmed Company, for treatment of this condition.

Research Objectives

Primary objective:

Effectiveness and safety of Embella® in reducing submental fat

Secondary objective:

Effectiveness assessment of Embella® in improving SMF grading Effectiveness assessment of Embella® in reducing submental fat diameter


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 65 years.
* Individuals with unwanted submental fat of any severity.
* Ability to comply with visit schedules and study procedures.
* Signed informed consent form and agreement to a 3-month follow-up.

Exclusion Criteria:

* Any previous intervention for the treatment of submental fat (SMF).
* Specific anatomical features or previous damage to the intervention site (e.g., scars, liposuction, swallowing difficulties, enlarged thyroid or lymph nodes) that could interfere with the assessment of intervention outcomes.
* Evidence of submental enlargment due to reasons other than SMF.
* History of dysphagia.
* Body mass index (BMI) \> 30 kg/m².
* Individuals currently on a weight loss program.
* History of allergy to any components of the drug or local anesthetics.
* Presence of any inflammation, active infection, unhealed wounds, or skin lesions in the injection area.
* Use of any anticoagulants, NSAIDs, or any other medications that increase the risk of coagulation disorders within 7 days before injection.
* Unrealistic expectations.
* Pregnant or breastfeeding women.
* Individuals on sodium-restricted diets, such as those with uncontrolled hypertension.

Primary outcomes:
measure: A minimum of one grade improvement in the standard submental fat (SMF) assessment grading
timeFrame: weeks 4 and 12 after the last injection
Secondary outcomes:
measure: Measurement of submental fat thickness
timeFrame: Weeks 4 and 12 after the last injection
measure: Pain intensity was assessed using the VAS from 0 to 10
timeFrame: day 1, week 4 and 8
measure: Subject satisfaction was assessed using the VAS from 0 to 10,
timeFrame: week 4 and 12 after the last injection
measure: Assessment of all adverse events immediately after the injections and during the study period.
timeFrame: Immediately after all of the injections and at weeks 4 and 12 after the last injection
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Center for Research and Training in Skin Diseases and Leprosy
Study officials:
References: