NCT05486910

Management of Side-Effects of Anti-Acne Treatment by a Cosmetic Routine

Evaluation of the Management of Side-Effects of Anti-Acne Treatment by a Cosmetic Routine Following Failure of the Usual Cosmetic Routine

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 44 (actual)
• Sponsor: Cosmetique Active International · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

Summary

Retinoid-based topical acne treatment may induce local tolerance issues such as erythema, dryness, stinging and burning sensations that may reduce adherence and efficacy. The tested regimen (cream and cleanser) has been specifically developed to rebalance the skin microbiome and compensate side-effects of topical treatments (hydration, skin barrier repair) together with an action on skin imperfections and marks. This open-label study was conducted in subjects aged 12 years and over with sensitive skin (\>2 on a sensitivity composite score from 0-3) treated for at least one month with the fixed-dose gel combination and presenting with treatment-related skin intolerance.

Detailed description

The study on the evaluation of the management of side-effects of an anti-acne treatment by a cosmetic routine (cleanser and cream) following failure of the usual cosmetic routine has been conducted under dermatological control by Dermscan that is certified by the International Standards Organization (ISO) 9001-2015. Each study report is subjected to a quality inspection by a proofreader member of Dermscan not involved in the audited study. The inspection of the study report allows to confirm that the results reflect exactly the study raw data and that the study fulfills any standard and regulatory requirements. Regarding the statistical analysis, data obtained for each parameter, at each measurement time and on each zone are presented in raw value tables. The tables also show the descriptive statistics: means, medians, minima, maxima, standard errors of the means (SEM), confidence intervals of 95% (CI 95%) of these values as well as the variations and percentage variations. They also present the results of the statistical analysis. Participants have the right to exit from the study at any time and for any motive in compliance with the Helsinki Declaration (1964) and its successive updates. The investigator can also interrupt the subject participation in the study prematurely in the case of a disease occurrence, a pregnancy or the occurrence of an adverse reaction. The personnel in charge of the study collects data into individual case report forms in electronic or paper format and/or directly from measurement software. When information is collected in paper format, the double data entry is then done from these supports by the designed operator(s), without any interpretation, in specific EXCEL databases. The Project Manager or assistant checks the double data entry by comparing both databases. Then the coherence of the whole data set is checked as well as formulas used in the EXCEL tables (calculation formulas, selected data…). When all the controls are done, the database is locked.

Conditions

• Acne

Timeline

• Start date: 2021-04-29
• Primary completion: 2021-07-29
• Completion: 2021-07-29
• First posted: 2022-08-04
• Last updated: 2022-08-04

Locations

1 site across 1 country: Poland