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

Terminated

• Conditions: Submental Fullness
• Interventions: Drug: BELKYRA Inj.

• Registration Number: NCT03691415
• Lead Sponsor: Allergan

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-07
• Study First Submitted: 2018-09-28
• Study First Submitted QC: 2018-09-28
• Study First Posted: 2018-10-01
• Primary Completion: 2020-04-14
• Study Completion: 2020-04-14
• Status Verified: 2020-10
• Last Update Submitted: 2020-12-03
• Last Update Posted: 2020-12-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 71

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BELKYRA Inj.	BELKYRA Inj.	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.

Primary Outcome Measures

Name	Time	Method
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".
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)

Trial Locations

Locations (4)

Oracle-Dermatology; 🇰🇷 Daejeon, Korea, Republic of

(Apgujeong) Oracle-Dermatology; 🇰🇷 Seoul, Korea, Republic of

Dream-Dermatology; 🇰🇷 Seoul, Korea, Republic of

Goldenview plastic surgery; 🇰🇷 Seoul, Korea, Republic of