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
NCT ID: NCT03691415
Last Updated: 2020-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
71 participants
OBSERVATIONAL
2018-09-07
2020-04-14
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
BELKYRA Inj.
Patient will be administered BELKYRA Inj. at least once and the interval between treatments not less than 1 month apart.
Interventions
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BELKYRA Inj.
Patient will be administered BELKYRA Inj. at least once and the interval between treatments not less than 1 month apart.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who have consented to the study and who have signed the private information protection act form or ICF
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Suzanne St. Rose, DVM, MSc, PhD
Role: STUDY_DIRECTOR
Allergan
Locations
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Oracle-Dermatology
Daejeon, , South Korea
Goldenview plastic surgery
Seoul, , South Korea
(Apgujeong) Oracle-Dermatology
Seoul, , South Korea
Dream-Dermatology
Seoul, , South Korea
Countries
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Related Links
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Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact [email protected] for assistance."
Other Identifiers
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EUPAS23762
Identifier Type: OTHER
Identifier Source: secondary_id
CMO-EPI-FAS-0537
Identifier Type: -
Identifier Source: org_study_id