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Optimization of atopic dermatitis treatment that requires second-line systemic therapy through multiomic predictive models of treatment response (DermAtOmics-II)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506165-62-00
Acronym
DermAtOmics-II
Enrollment
0
Registered
2023-08-01
Start date
2023-09-25
Completion date
Unknown
Last updated
2025-08-20

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

Conditions

Atopic dermatitis

Brief summary

Percentage of patients with primary non-response to second-line treatment. Defined as fail to achieve EASI-75 (a 75% improvement in EASI score) at week 16 of follow-up.

Detailed description

Percentage of patients achieving EASI-75 at week 6 of follow-up., Percentage of patients reaching 90 percentage (EASI-90) improvement from baseline during follow-up., Time to treatment failure with cyclosporine defined as EASI ≤ 50 during follow-up after week 16., Mean percentage of change in EASI score from baseline to week 16., Percentage of change in SCORAD from baseline to the primary endpoint (week 16)., Percentage of patients experiencing an improvement of at least 75% in SCORAD from the baseline value., Reduction of IGA (investigator global assessment) at week 16., Time to IGA score of 0/1 (clear or almost clear)., Change of BSA (Body surface area) involment at week 16, Change in NRS (numerical rating scale) at week 16, Change in RECAP at week 16., Percentage of patients having a variation of 4 points in their improvement in DLQI (Dermatology Life Quality Index)., Change in POEM (Patient Oriented Eccema Measure) and DLQI (Dermatology Life Quality Index) at week 16., Change in the score of the different scales in the different follow-up visits compared to baseline visit., Rate of adverse events associated to treatment.

Interventions

Sponsors

Hospital Universitario La Paz
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Percentage of patients with primary non-response to second-line treatment. Defined as fail to achieve EASI-75 (a 75% improvement in EASI score) at week 16 of follow-up.

Secondary

MeasureTime frame
Percentage of patients achieving EASI-75 at week 6 of follow-up., Percentage of patients reaching 90 percentage (EASI-90) improvement from baseline during follow-up., Time to treatment failure with cyclosporine defined as EASI ≤ 50 during follow-up after week 16., Mean percentage of change in EASI score from baseline to week 16., Percentage of change in SCORAD from baseline to the primary endpoint (week 16)., Percentage of patients experiencing an improvement of at least 75% in SCORAD from the baseline value., Reduction of IGA (investigator global assessment) at week 16., Time to IGA score of 0/1 (clear or almost clear)., Change of BSA (Body surface area) involment at week 16, Change in NRS (numerical rating scale) at week 16, Change in RECAP at week 16., Percentage of patients having a variation of 4 points in their improvement in DLQI (Dermatology Life Quality Index)., Change in POEM (Patient Oriented Eccema Measure) and DLQI (Dermatology Life Quality Index) at week 16., Change in t

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026