Multicenter, national non-interventional study including a registry and a prospective cohort of patients with common scab. (Epigale)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/43280
• EU PAS number:
  EUPAS43279
• Study ID:
  43280
• Official title and acronym:
  Multicenter, national non-interventional study including a registry and a prospective cohort of patients with common scab. (Epigale)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  Main objective: to evaluate the% of patients cured on day 28 (±7 days) in patients with common scab and treated with Ascabiol® in real life conditions. Secondary objectives: to describe • Epidemiological and clinical characteristics of treated patients • Respect of the prescription methods (dosage and good use) of the 10% benzyl benzoate emulsion • treatment of the family • treatment of the environment • Predicting factors of treatment success at D28  7 days (S4) • Recurrence rate at J84 (S12) and predictors of recurrence. • Registry data
• Study status:
  Finalised

Research institutions and networks

Institutions

Multiple centres: 19 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 18/09/2018

Study start date

Planned: 01/11/2018

Actual: 28/01/2019

Date of final study report

Planned: 01/01/2020

Actual: 02/03/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Zambon France

Study protocol

Initial protocol

STUDY PROTOCOL

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable