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

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

Study Overview

• Status: Terminated
• Conditions: Submental Fullness
• Intervention / Treatment: Drug: BELKYRA Inj.

• Study Type: Observational
• Enrollment (Actual): 71

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daejeon, Korea, Republic of, 35234
    • Oracle-Dermatology
  • Seoul, Korea, Republic of, 06010
    • Goldenview plastic surgery
  • Seoul, Korea, Republic of, 06022
    • (Apgujeong) Oracle-Dermatology
  • Seoul, Korea, Republic of, 06030
    • Dream-Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study will include adult patient is an adult (≥ 18 years of age) in South Korea treated with BELKYRA for the improvement of moderate to severe convexity or fullness associated with submental fat in adults

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: BELKYRA Inj.; Patient will be administered BELKYRA Inj. at least once and the interval between treatments not less than 1 month apart.; 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)

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Study Director: Suzanne St. Rose, DVM, MSc, PhD, Allergan

Publications and helpful links

Helpful Links

• Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance."

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2018
• Primary Completion (Actual): April 14, 2020
• Study Completion (Actual): April 14, 2020

Study Registration Dates

• First Submitted: September 28, 2018
• First Submitted That Met QC Criteria: September 28, 2018
• First Posted (Actual): October 1, 2018

Study Record Updates

• Last Update Posted (Actual): December 7, 2020
• Last Update Submitted That Met QC Criteria: December 3, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Double Chin Fat Reduction
• Additional Relevant MeSH Terms: Gastrointestinal Agents; Cholagogues and Choleretics; Deoxycholic Acid
• Other Study ID Numbers: CMO-EPI-FAS-0537; EUPAS23762 (Other Identifier: EU PAS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No