Effectiveness and Tolerance of Cicaplast Baume B5 After Superficial CO2 Laser Resurfacing

Launched by COSMETIQUE ACTIVE INTERNATIONAL · Jun 14, 2024

Keywords

ClinConnect Summary

This clinical trial is conducted in accordance with the protocol, the Helsinki declaration (1964) and subsequent amendments, and the International Council on Harmonisation (ICH) Good Clinical Practice (GCP), and in compliance with applicable regulatory requirements.

Statistical method: analysis will be performed using R software version 4.0.2. or higher. All statistical tests will be two-sided and at the 5% level of significance. Normality tests will be at the 1% level of significance (Shapiro-Wilk). All efficacy evaluation will be done on the Per Protocol Set.

The categorical variables a...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • phototype II and III on the Fitzpatrick scale
• • subjects with normal clinical examination and medical history compatible with the study
• Exclusion Criteria:
• • subject with underlying pathology that may interfere with the interpretation of the study results (dermatological history of psoriasis, eczema, urticaria... or suspicion/history of allergies to cosmetics), skin abnormality (scars, excessive hair growth, tattoos...) in the test areas (back, midline), systemic pathology
• • subject with excessive exposure to natural (sun) or artificial (tanning salon) ultraviolet light (UV) 4 weeks prior to the initial visit or who anticipates such exposure during the study
• • subject who has taken systemic treatment for more than 5 days in the month prior to inclusion