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

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  Ascabiol
• Medical condition to be studied:
  Acarodermatitis

Population studied

• Short description of the study population:
  Patients with common scab and treated with Ascabiol® in real life conditions; Criteria for participation in the registry: all patients; - more than 1 month old; - outpatient; - visiting for untreated common scab; - giving their oral consent to participation (over 18 years) or for which the parents give their participation agreement (under 18 years).; Criteria for participation in the cohort: all patients; - included in the registry; - treated with Ascabiol® monotherapy; ; Criteria for non-participation in the registry and monitoring:; - known pregnancy; - breastfeeding; - hyperkeratotic scabies; - scabies already treated in the last 6 month
• Age groups:
  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  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)
• Special population of interest:
  Other
• Special population of interest, other:
  Scabies
• Estimated number of subjects:
  300

Study design details

• Main study 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.
• Data analysis plan:
  The analysis of the primary endpoint will be conducted on all patients included in the cohort and reviewed at D28 (±7 days). The 95% confidence interval will be calculated. Sensitivity analyzes will be conducted. Secondary end points: the analyzes of the secondary end points will be descriptive. The search for predictors of treatment failure on day 28 (W4) and recurrence on day 84 (W12) will be done by univariate analyzes to select the factors to be considered in a multivariate logistic regression model.

Documents

Study results

EPIGALE Rapport VF 2021 Mars 08 + Signatures

Study publications

Caumes E, Marty M, Cadot M, Boulanger P, Rousseaux C, Petit A. A prospective co…