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 identification

• EU PAS number:
  EUPAS23762
• Study ID:
  25581
• Official title and acronym:
  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
• DARWIN EU® study:
  No
• Study countries:
  Korea, Republic of
• Study description:
  This study is a prospective, observational postmarketing surveillance (PMS) conducted under the requirements of the Korean Ministry of Food and Drug Safety (MFDS) to evaluate the safety and effectiveness of BELKYRA Inj. in routine clinical settings when administered to patients in Korea for the improvement of moderate to severe convexity or fullness associated with SMF in adults.
• Study status:
  Ongoing

Research institutions and networks

Institutions

DreamCIS

Study timelines

Date when funding contract was signed

Planned: 30/04/2018

Actual: 15/12/2017

Study start date

Planned: 30/09/2018

Actual: 07/09/2018

Data analysis start date

Planned: 31/03/2023

Date of final study report

Planned: 30/11/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Allergan

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only

Other study registration identification numbers and links

CMO-EPI-FAS-0537