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

NCT03691415 | Terminated

• 2 other identifiers: CMO-EPI-FAS-0537EUPAS23762
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 4

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

Conditions

Submental Fullness

Keywords

Double Chin Fat Reduction

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (1)

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.

Interventions

BELKYRA Inj. DRUG

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

Also known as: Deoxycholic acid

BELKYRA Inj.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Eligible and consenting Korean patients
• Patients who have consented to the study and who have signed the private information protection act form or ICF

You may not qualify if:

• 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.)
• Pregnant women
• Renal impairment patients
• Hepatic impairment patients
• Patients with severe laxity

Sponsors & Collaborators

• Allergan: lead

Study Sites (4)

Oracle-Dermatology

Daejeon, 35234, South Korea

Location

Goldenview plastic surgery

Seoul, 06010, South Korea

Location

(Apgujeong) Oracle-Dermatology

Seoul, 06022, South Korea

Location

Dream-Dermatology

Seoul, 06030, South Korea

Location

Related 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."

MeSH Terms

Interventions

Deoxycholic Acid

Intervention Hierarchy (Ancestors)

Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Study Officials

• Suzanne St. Rose, DVM, MSc, PhD

  Allergan

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 1, 2018
• Study Start: September 7, 2018
• Primary Completion: April 14, 2020
• Study Completion: April 14, 2020
• Last Updated: December 7, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (4)