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
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|ClinicalTrials.gov Identifier: NCT03691415|
Recruitment Status : Terminated (Study discontinued due to business decisions.)
First Posted : October 1, 2018
Last Update Posted : December 7, 2020
|Condition or disease||Intervention/treatment|
|Submental Fullness||Drug: BELKYRA Inj.|
|Study Type :||Observational|
|Actual Enrollment :||71 participants|
|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|
|Actual Study Start Date :||September 7, 2018|
|Actual Primary Completion Date :||April 14, 2020|
|Actual Study Completion Date :||April 14, 2020|
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 Name: Deoxycholic acid
- 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)
- 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".
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03691415
|Korea, Republic of|
|Daejeon, Korea, Republic of, 35234|
|Goldenview plastic surgery|
|Seoul, Korea, Republic of, 06010|
|Seoul, Korea, Republic of, 06022|
|Seoul, Korea, Republic of, 06030|
|Study Director:||Suzanne St. Rose, DVM, MSc, PhD||Allergan|