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

Investigation of flare and remission in atopic dermatitis in an integrated longitudinal study: effects of systemic treatment with cyclosporine A - EXP-1392

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49815

Enrollment

Registered

2019-10-28

Start date

2019-12-02

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atopic dermatitis eczema

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Molecular signatures (including lesional and nonlesional gene expression, immunohistochemistry, serum proteomics, and microbiome analysis) at baseline and at two (serum only), and four weeks after initiation of CsA treatment.	—

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results