Drug Use Result Survey of Botox Vista® Injection 50 Units

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/30867
• EU PAS number:
  EUPAS16104
• Study ID:
  30867
• Official title and acronym:
  Drug Use Result Survey of Botox Vista® Injection 50 Units
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  Objective The purpose of this survey is to collect and evaluate the information on the safety, efficacy and proper use of Botox Vista® Injection 50 Units (hereinafter referred to as “Botox”) in adult patients less than 65 years, who undergo the treatment of expression lines of lateral canthus (crow’s feet lines) during actual use. Inclusion Criteria1) Patients who undergo the treatment with Botox for the first time (initial administration group) or2) Patients with an experience of the treatment with Botox (repeated administration group)3) Less than 65 years at the time of treatmentSample Size1080 patientsFollow-up PeriodAll patients shall be followed up from time of study drug injection to 6 months after study drug administration Total Survey Period2 years and 6 months after product launch Survey Items to be Collecteda) Information on Institutionb) Identifying Information on Patientc) Patient Background Informationd) Prior Treatment History for Facial Wrinkles e) Information on Current Botox Administrationf) Information on Efficacy Evaluation (this includes evaluation of degree of winkle improvement by patient and physician, patient satisfaction with treatment)g) Use of Commitment Drug h) Information on Antibody Examination for Botulinum Toxin Type AI) Presence or Absence of AEsJ) Type of AEK) Evaluation of AE Relationship to Study DrugL) Exposure to Study Drug During Pregnancy
• Study status:
  Ongoing

Research institution and networks

Institutions

Quintiles

Study timelines

Date when funding contract was signed

Planned: 14/06/2016

Study start date

Planned: 28/12/2016

Actual: 21/12/2016

Date of final study report

Planned: 22/08/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Allergan

Study protocol

Initial protocol

(Japan) Botox in CFL E-DUI_protocol_20160316 (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