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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03691415

Enrollment

Registered

2018-10-01

Start date

2018-09-07

Completion date

2020-04-14

Last updated

2020-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Submental Fullness

Keywords

Double Chin Fat Reduction

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

Interventions

DRUGBELKYRA Inj.

Patient will be administered BELKYRA Inj. at least once and the interval between treatments not less than 1 month apart.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline in Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)	Baseline, Follow up visit (within 3 months of injection)	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)
Change from baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS)	Baseline, Follow up visit (within 3 months of injection)	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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026