Moisturiser effect on the skin barrier in atopic dermatitis

Phase 1

• Conditions: Atopic dermatitis; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: CTIS2023-508560-29-00
• Lead Sponsor: ACO Hud Nordic AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-08
• Study Completion: 2024-03-14
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Participants = 18 years old, A history of atopic dermatitis according to UK working party criteria, Willing and able to provide informed consent

Exclusion Criteria

Substantial flare-up of atopic dermatitis more than minimal (not manageable with moisturiser only) during ideally within the last 6 months, Eczema on the volar forearms, Participants with known or suspected allergies or contraindications to any of the IPs and AxMP ingredients, Participants unwilling to refrain from using prohibited medication including moisturisers (other than the IP, the AxMP and the standard soap for washing), Female participants who, according to the participant, is pregnant or breast-feeding, or plans to become pregnant during the study, Participants judged by the investigator to be inappropriate for the trial., Any serious current medical condition which, in the opinion of the investigator, may interfere with the evaluation of the results or may be contraindicated by the use of the investigational products, Atopic dermatitis targeted systemic therapy as well as any other immunomodulatory systemic therapy over more than 8 days in past 12 months (glucocorticoids, biologicals, cyclosporines, JAK inhibitors, off-label azathioprine, mycophenolate-mofetil, alitretionin, photo therapy), Any treatment with TCS' or other established topical treatment for AD within the last 6 months prior screening and throughout the study. Except the two allowed corticosteroids for treatment of flare-up during the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether applying a new moisturiser (Propyduo®; test product) for 4 weeks is superior in terms of skin barrier strengthening, when compared with (1) no treatment and (2) a reference product (Propyless®; reference product 1) in adults with a history of atopic dermatitis.;Secondary Objective: To assess the skin barrier strengthening effects of the test product compared with a reference product (Canoderm®; reference product 2) in adults with a history of atopic dermatitis. To determine whether there is a difference between the test product and (1) no treatment and (2) the two reference products in: 1.Resting skin barrier function 2.Skin redness 3.Irritant reactions 4.Skin capacitance 5.Skin pH 6.Product consumption;Primary end point(s): Comparison of IPs on Trans Epidermal Water Loss (TEWL) on visit 3 and visit 5 between: •test product vs no treatment •test product vs Propyless®