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

Submental Fullness Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03691415
• Other study ID #: CMO-EPI-FAS-0537
• Secondary ID: EUPAS23762
• Status: Terminated
• Start date: September 7, 2018
• Est. completion date: April 14, 2020

Study information

• Verified date: October 2020
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 71
• Est. completion date: April 14, 2020
• Est. primary completion date: April 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Submental Fullness

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Oracle-Dermatology	Daejeon
Korea, Republic of	(Apgujeong) Oracle-Dermatology	Seoul
Korea, Republic of	Dream-Dermatology	Seoul
Korea, Republic of	Goldenview plastic surgery	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)

External 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."