Moisturiser effect on the skin barrier in atopic dermatitis
Key facts
- Where
- Schenefeld, NémetországSee the site
- Phase
- 2. fázis
Where in Németország
- SGS proderm GmbHSchenefeld, NémetországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- ACO Hud Nordic AB
- Trial code
- EU 2023-508560-29-00
- Record updated
- 2024. április 15.
- Original description
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.Read full original descriptionShow less
A randomised controlled trial of a moisturiser for treatment of dry skin in atopic dermatitis: effect on the skin barrier in adults with a history of eczema
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.
Inclusion: Participants ≥ 18 years old; A history of atopic dermatitis according to UK working party criteria; Willing and able to provide informed consent.
Exclusion: Participants unwilling to refrain from using prohibited medication including moisturisers (other than the IP, the AxMP and the standard soap for washing); 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; Participants with known or suspected allergies or contraindications to any of the IPs and AxMP ingredients; 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; 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.