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Identifying key immunological and molecular pathways that drive disease exacerbation in atopic dermatitis

Identifying key immunological and molecular pathways that drive disease exacerbation in atopic dermatitis - Immunological and molecular pathways in atopic dermatitis

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON42484
Enrollment
90
Registered
2015-11-04
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

atopic eczema eczema

Interventions

None listed

Sponsors

MedImmune Biotech
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * adults (*18 years of age);and for: * group a (n

Exclusion criteria

Exclusion criteria: * on systemic therapy at time of recruitment * previous receipt of any investigational agent within 4 weeks prior to recruitment or within 5 half-lives of the investigational agent, whichever is longer *evidence of other skin conditions, including, but not limited to, T-cell lymphoma or allergic contact dermatitis *not willing to be biopsied;group d: a history of AD, allergic rhinitis or asthma.

Design outcomes

Primary

MeasureTime frame
- The presence of a molecular signature of disease exacerbation in the skin and peripheral blood of patients with moderate to severe atopic dermatitis will be assessed using the following parameters: - Composite scores for disease activity and treatment response and patient reported outcome measures (PROMS): o The Six Area, Six Sign Atopic Dermatitis (SASSAD) o SCORing AD (SCORAD) o Eczema Area and Severity Index (EASI) o Investigator Global Assesment (IGA) o Patient Oriented Eczema Measure (POEM) o Self-assessed EASI (SA-EASI) - Biomarkers measured in serum and DBS (Luminex: panel of biomarkers including TARC, MDC, PARC, IL-22, sE-selectin, sIL-2R and IL-16 based on our previous findings and somalogics: http://www.somalogic.com/) - Molecular analysis of gene expression from peripheral blood mononuclear cells (PBMC) - Molecular analysis of gene expression from skin biopsies - Immunohistochemistry skin biopsies

Secondary

MeasureTime frame
*Define the propensity of S. aureus colonization/infection of patients and association with disease exacerbation *Define the association with asthma and how severity of atopic dermatitis correlates with asthma severity

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)