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

Study Identifier
CMO-EPI-FAS-0537
CT.gov Identifier
NCT03691415
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

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Study Details

Medical Condition
  • Facial Aesthetics - Fillers
    • Study Drug
  • BELKYRA Inj.
    • Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion 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

    Protocol 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

    Study Locations

    Location
    Status
    Location
    Oracle-Dermatology
    Daejeon, Republic of Korea, 35234
    Status
    Not applicable
    Location
    Goldenview plastic surgery
    Seoul, Republic of Korea, 06010
    Status
    Not applicable
    Location
    (Apgujeong) Oracle-Dermatology
    Seoul, Republic of Korea, 06022
    Status
    Not applicable
    Location
    Dream-Dermatology
    Seoul, Republic of Korea, 06030
    Status
    Not applicable