Evaluation of the Safety and Effectiveness of BOTOX® Injection 50 Units (ClostridiumBotulinum Toxin Type A) for the Treatment of Patients with Moderate to Severe Lateral Canthal Lines (Crow’s Feet Lines) With or Without Simultaneous Glabellar Lines Treatment:A Postmarketing Surveillance Study in Korea

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/34190
• EU PAS number:
  EUPAS16150
• Study ID:
  34190
• Official title and acronym:
  Evaluation of the Safety and Effectiveness of BOTOX® Injection 50 Units (ClostridiumBotulinum Toxin Type A) for the Treatment of Patients with Moderate to Severe Lateral Canthal Lines (Crow’s Feet Lines) With or Without Simultaneous Glabellar Lines Treatment:A Postmarketing Surveillance Study in Korea
• DARWIN EU® study:
  No
• Study countries:
  Korea, Democratic People's Republic of
• Study description:
  The purpose of this prospective, observational postmarketing surveillance (PMS) study is to evaluate the safety and effectiveness of BOTOX® for the treatment of patients with moderate to severe lateral canthal lines (crow’s feet lines) as required by the Korea Ministry of Food and Drug Safety (MFDS). The study will be conducted in at least 600 adult (18 to 75 years of age) Korean patients who are treated with BOTOX injection from a 50 units (U) vial at the labeled dose for crow’s feet lines only (BOTOX 24 U) or crow’s feet lines and glabellar lines simultaneously (BOTOX 24 U for crow’s feet lines) as per clinical practice. Each patient will have one follow-up contact within 3 months of the BOTOX treatment to collect safety and effectiveness data on crow’s feet lines. The study will sequentially enroll eligible Korean patients treated with BOTOX, with a signed private information protection act form or informed consent form (ICF), at each of the selected clinic(s)/hospital(s) from the date of contract until at least 600 patients have completed one follow-up contact during the study period. The decision to treat a patient with BOTOX is determined by the physician and patient prior to the decision to include the patient in the study. Safety information and effectiveness as assessed by the investigator and by the patient will be collected during any in-office visit within 3 months of the index BOTOX treatment or before receiving a new BOTOX treatment if the new treatment occurs within 3 months. Safety information and the patient’s assessment of effectiveness may also be collected via telephone contact if patients do not have an in-office visit during this 3-month period. The investigator’s assessment of effectiveness will not be collected over the telephone. The analyses will be descriptive in nature. The study will be completed within 4 years after product/indication approval Periodic and final reports will be sent to the MFDS.
• Study status:
  Finalised

Research institutions and networks

Institutions

DreamCIS

Study timelines

Date when funding contract was signed

Planned: 20/05/2014

Actual: 25/08/2014

Study start date

Planned: 30/09/2014

Actual: 30/09/2014

Date of final study report

Planned: 03/05/2018

Actual: 02/05/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Allergan

Study protocol

Initial protocol

191622-147 Protocol_ENGL.Redacted (2)

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

191622-147