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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Allergan
- Enrollment
- 71
- Locations
- 4
- Primary Endpoint
- Change from baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: BELKYRA Inj. (Drug)
Outcomes
Primary Outcomes
Change from baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
Time Frame: 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)
Time Frame: 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)
Secondary Outcomes
No secondary outcomes reported