CTIS2023-508560-29-00
Active, not recruiting
Phase 1
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 - CSCI-SKT-B1001
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Atopic dermatitis
- Sponsor
- ACO Hud Nordic AB
- Enrollment
- 55
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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