Dermscan has implemented a quality management system which has been certified by the International Standards Organization (ISO 9001: 2015). This quality assurance system includes appropriate Good Clinical Practices (GCP) and regulation requirements. The proofreader is not involved in the audited study. A certificate of quality inspection signed by the person who checked the report is enclosed in each study.~Statistical method~Regarding the descriptive analysis, the quantitative data is summarized using the following statistics by time point:~Number of values~Mean~Median~Standard deviation (SD)~Minimum value~Maximum value.~Are summarized in frequency (N) and percentage (%) by time point:~the Investigator's Global Assessment (IGA) score assessed by the investigator using a 6-point scale~the soothing effect assessed by the subject using a 4-point scale for the parameters pain and pruritus~each global tolerance score assessed by the investigator and by the subject using a 4-point scale.~The score of anti-irritating effect (SCOre de REparation de l'EPIderme= SCOREPI) is summarized using statistics for quantitative variables at each time point.~The local signs of irritated area assessed using a 4-point scale (erythema, desquamation, pigmentation, cracks, oedema) are summarized in frequency (N) and percentage (%) and by time point and by parameter.
The aim of this open, before/after, multicentric study is to assess the effect and tolerance of Cicaplast Baume B5 in patients having a skin irritation (irritative and cracked dermatitis, dry eczematids, rubbing irritation, ...) under dermatological control. Patients are asked to apply the product at least twice a day until complete recovery (maximum 21 days).