NCT05807113

Assessment of Skin Tolerance and Efficacy of a Cosmetic Product After 5 Days of Use on Subjects With Atopic Dermatitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Bionorica SE · Industry
• Sex: All
• Age: 6 Months – 65 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to compare the efficacy and tolerability and of a cosmetic product to one that is already available on the market (benchmark product). Efficacy is assessed by instrumental measurements of skin condition, clinical examinations, and questionnaires.

Detailed description

The objective of this exploratory study is to investigate the efficacy and tolerability of a cosmetic product on subjects with atopic dermatitis after 5 days of use in comparison to a benchmark product. The efficacy will be evaluated via instrumental measurements of skin hydration by Corneometer, transepidermal water loss by Tewameter and erythema by Chromameter as well as by evaluation of itch by using a Numerical Rating Scale (NRS). For efficacy and tolerability evaluation an objective and, in the case of adults, an additional subjective dermatological assessment will be performed.

Conditions

• Atopic Diathesis
• Eczema-prone Skin

Interventions

Type	Name	Description
OTHER	Atopi intensive care BNO 3731	Crem twice daily
OTHER	Benchmark product	Crem twice daily

Timeline

• Start date: 2022-02-15
• Primary completion: 2022-02-22
• Completion: 2022-02-22
• First posted: 2023-04-11
• Last updated: 2023-04-11

Locations

1 site across 1 country: Germany