NCT05790083

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Bionorica SE · Industry
• Sex: All
• Age: 2 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Atopic Dermatitis
• Eczema-Prone Skin

Interventions

Type	Name	Description
OTHER	Body Lotion and Intensive Care	Body Lotion, applied twice daily on whole body, for 3 months. Intensive Care, applied as needed on affected body areas.

Timeline

• Start date: 2023-01-03
• Primary completion: 2023-03-30
• Completion: 2023-03-30
• First posted: 2023-03-29
• Last updated: 2023-03-29

Locations

1 site across 1 country: Germany