2023-508560-29-00CompletedPhase 2
Moisturiser effect on the skin barrier in atopic dermatitis
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 15 Apr 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 55 (actual)
- First submitted
- 8 Oct 2023
- Start date
- 7 Dec 2023
- Lead sponsor
- ACO Hud Nordic AB
- Diseases
- Atopic dermatitis (eczema)
- EU CT number
- 2023-508560-29-00
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 55
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Participants with known or suspected allergies or contraindications to any of the IPs and AxMP ingredients
Other
- 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.
Who the study is looking for
- Participants ≥ 18 years old
- A history of atopic dermatitis according to UK working party criteria
- Willing and able to provide informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SGS proderm GmbH | Schenefeld | Germany | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.