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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
Sponsor:
Information provided by (Responsible Party):
Allergan

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

Condition or disease Intervention/treatment
Submental Fullness Drug: BELKYRA Inj.

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Study Type : Observational
Actual Enrollment : 71 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


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 Name: Deoxycholic acid




Primary Outcome Measures :
  1. 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)

  2. 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".



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

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


Locations
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Korea, Republic of
Oracle-Dermatology
Daejeon, Korea, Republic of, 35234
Goldenview plastic surgery
Seoul, Korea, Republic of, 06010
(Apgujeong) Oracle-Dermatology
Seoul, Korea, Republic of, 06022
Dream-Dermatology
Seoul, Korea, Republic of, 06030
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Suzanne St. Rose, DVM, MSc, PhD Allergan
Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03691415    
Other Study ID Numbers: CMO-EPI-FAS-0537
EUPAS23762 ( Other Identifier: EU PAS )
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: December 7, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Allergan:
Double Chin Fat Reduction
Additional relevant MeSH terms:
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Deoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents