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 type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name, other:
  Belkyra
• Anatomical Therapeutic Chemical (ATC) code:
  (D11AX24) deoxycholic acid

  deoxycholic acid
• Medical condition to be studied:
  Fat tissue increased

Population studied

• Short description of the study population:
  This study will include adult patients (≥ 18 years of age) in South Korea treated with BELKYRA Inj. for the improvement of moderate to severe convexity or fullness associated with SMF in adults according to the approved label.
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  600

Study design details

• Main study objective:
  1. To assess the safety profile of BELKYRA routine Inj. in routine clinical practice in adult patients treated for SM fullness due to SMF; 2. To assess the effectiveness of BELKYRA Inj. in routine clinical practice in adult patients treated for SM fullness due to SMF.
• Setting:
  BELKYRA Inj. is expected to be mainly used at clinics (specializing in dermatology, plastic surgery, and aesthetic medicine), university hospitals, and general hospitals with dermatology, plastic surgery, or aesthetic medicine departments; therefore, surveillance will be mainly conducted by collecting relevant information on treated patients from contracted clinicians at these locations.
• Outcomes:
  All adverse events that occur during and/or after administration of BELKYRA injection treatment throughout the follow-up period, Investigators' and patients' rating of improvement of fullness associated with submental fat, during follow-up using validated scales.
• Data analysis plan:
  • Full analysis set - patients whose case report form were retrieved: the demographic data, baseline characteristics including diagnosis, treatment history, concurrent disease, etc. and concomitant medications ; • Safety analysis set– patients who received an initial BELKYRA Inj. treatment, completed the Follow-up/Exit Visits (non-treatment) within 3 months of the last BELKYRA Inj. treatment for safety information (via in-office visit or telephone) with case report forms retrieved; • Effectiveness analysis– patients who received an initial BELKYRA Inj. treatment and have been evaluated for effectiveness of BELKYRA Inj. for the treatment of excess SMF by the investigator or by the patient.