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Skin Efficacy and Tolerability of a Cosmetic Product Combination Over 3 Months in Subjects With Atopic Eczema — AtoCare-OS  

Atopic Dermatitis Clinical Trial

Official title:
Assessment of the Short- and Long-Term Skin Efficacy and Tolerability of a Cosmetic Product Combination of Body Lotion and Intensive Care Over 3 Months in Subjects With Atopic Eczema

Clinical Trial Summary

The aim of this exploratory study is to investigate the short- and long-term efficacy and tolerability of a cosmetic product combination consisting of a body lotion and an intensive care product in subjects with atopic eczema over 3 months of use. Efficacy is assessed by instrumental measurements of skin condition (sub-panel), clinical examinations, and questionnaires.

Clinical Trial Description

The objective of this exploratory study is to investigate the short- and long-term efficacy and tolerability of a cosmetic product combination consisting of a body lotion and an intensive care product in subjects with atopic eczema over 3 months of use. For efficacy and tolerability evaluation, an objective dermatological assessment will be performed, in addition to assessing efficacy, the severity of atopic eczema will be assessed using the validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD). Further, the effect of the test product combination on symptom severity, disease control (recap of atopic eczema (RECAP)), quality of life and well-being will be evaluated by the subjects or the subjects' parents/ legal guardians. The subjects or the subjects' parents/ legal guardians will also document the frequency of flare-ups, required physician visits and the use of cortisone administration as well as their/ their child's well-being in a diary. Additionally, the influence of the test product combination on the skin barrier will be assessed in a sub-panel with dry legs by measuring the transepidermal water loss by Aquaflux and by sampling of biological material for analysis of skin lipids and corneocyte maturity before and after 3 months of product use. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05790083
Study type Interventional
Source Bionorica SE
Contact
Status Active, not recruiting
Phase N/A
Start date January 3, 2023
Completion date March 30, 2023
View Details
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