Investigation of flare and remission in atopic dermatitis in an integrated longitudinal study: effects of systemic treatment with cyclosporine A

Conditions: atopic dermatitis
eczema
10014982

Registration Number: NL-OMON49815

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

- adult patient with a flare of atopic dermatitis
- insufficient response to topical steroids
- intention to start cyclosporine A treatment

Exclusion Criteria

- systemic treatment for AD with an immunosuppressive/immunomodulating/biologic
agent within last 4 weeks
- Chronic or acute infection requiring treatment with oral or intravenous
antibiotics, anti-virals, anti-parasitics, anti-protozoals, or anti-fungals
within 4 weeks before the screening visit or superficial skin infections within
1 week before the baseline visit.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Molecular signatures (including lesional and nonlesional gene expression,<br /><br>immunohistochemistry, serum proteomics, and microbiome analysis) at baseline<br /><br>and at two (serum only), and four weeks after initiation of CsA treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Investigator*s Global Assessment (IGA) score at all visits<br /><br>- Eczema Area and Severity Index (EASI) score at all visits<br /><br>- Numeric Rating Scale (NRS) pruritus score at all visits<br /><br>- At least 50% reduction in EASI score (EASI50; yes/no) at all visits<br /><br>- AD Symptom Diary (ADSD) scores (itch, redness, pain, burning, and swelling)<br /><br>at all visits<br /><br>- Patient-Oriented Eczema Measure (POEM) score at all visits</p><br>