NCT05767333

Evaluation of Cicaplast in Subjects With Skin Irritation

Evaluation of Cicaplast in Subjects With Skin Irritation for 21 Days

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 109 (actual)
• Sponsor: Cosmetique Active International · Industry
• Sex: All
• Age: 3 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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.

Conditions

• Skin Diseases

Timeline

• Start date: 2021-10-11
• Primary completion: 2022-06-06
• Completion: 2022-06-06
• First posted: 2023-03-14
• Last updated: 2023-03-14

Locations

4 sites across 4 countries: United States, China, Mauritius, Poland