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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date September 28, 2018
First Posted Date October 1, 2018
Last Update Posted Date December 7, 2020
Actual Study Start Date September 7, 2018
Actual Primary Completion Date April 14, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 28, 2018)
  • 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".
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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
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
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition 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.
Other Name: Deoxycholic acid
Study Groups/Cohorts 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: Drug: BELKYRA Inj.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: December 3, 2020)
71
Original Estimated Enrollment
 (submitted: September 28, 2018)
600
Actual Study Completion Date April 14, 2020
Actual Primary Completion Date April 14, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT03691415
Other Study ID Numbers CMO-EPI-FAS-0537
EUPAS23762 ( Other Identifier: EU PAS )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Allergan
Study Sponsor Allergan
Collaborators Not Provided
Investigators
Study Director: Suzanne St. Rose, DVM, MSc, PhD Allergan
PRS Account Allergan
Verification Date October 2020