Evaluation of the Safety and Effectiveness of BELKYRA® Inj. for the Treatment of Patients With Submental Fullness Due to Submental Fat: A Postmarketing Surveillance Study in Korea

Study Overview
=================
Brief Summary
-----------------
The purpose of this PMS study is to evaluate the safety and effectiveness of BELKYRA Inj. used according to the dose specified in the instructions for use, for the treatment of patients with SM fullness due to SMF, through active investigation under routine clinical practice

Official Title
-----------------
Evaluation of the Safety and Effectiveness of BELKYRA® Inj. for the Treatment of Patients With Submental Fullness Due to Submental Fat: A Post Marketing Surveillance Study in Korea

Conditions
-----------------
Submental Fullness

Intervention / Treatment
-----------------
* Drug: BELKYRA Inj.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible and consenting Korean patients Patients who have consented to the study and who have signed the private information protection act form or ICF Exclusion Criteria: Patients having infection at the infection sites Patients presenting evidence of causes of enlarged submental area other than localized submental fat (E.g.: thyroid enlargement, enlarged submental salivary glands, cervical lymphadenopathy, etc.) Patients participating in an interventional clinical study, currently or within 30 days before enrollment, will not be eligible for inclusion in the study Pregnant women Renal impairment patients Hepatic impairment patients Patients with severe laxity

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BELKYRA Inj.<br>Each patient will be administered BELKYRA Inj. at least once and the interval between treatments not less than 1 month apart and follow-up within 3 months of the last treatment session. | Drug: BELKYRA Inj.<br>* Patient will be administered BELKYRA Inj. at least once and the interval between treatments not less than 1 month apart.<br>* Other names: Deoxycholic acid;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | A validated scale used by investigators to assess SM convexity/amount of SMF. Specifically, the CR-SMFRS ranges in whole number increments from 0 (absent submental convexity) to 4 (extreme submental convexity) | Baseline, Follow up visit (within 3 months of injection) | 
| Change from baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | Validated scale used by patients to evaluate SM size. Specifically, the PR-SMFRS asks patients to assess how much fat they have under their chins by selecting options ranging from no chin fat at all to a very large amount of chin fat. | Baseline, Follow up visit (within 3 months of injection) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Double Chin Fat Reduction