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Skin bioMARkers for Atopic Eczema Therapy Evaluation

NCT04194814 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2025-07-18

Study results available
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Summary

The study aims to investigate two new non-invasive technologies for assessing skin properties to identify and validate a range of safety biomarkers that may be considered useful as primary outcome measures for evaluating the safety of topical treatments in atopic dermatitis. The method of assessing these biomarker technologies will be to determine whether twice daily treatment with crisaborole (2%) ointment, compared to betamethasone valerate (0.1%) cream, for up to 4 weeks, may cause skin structure or function changes, like skin atrophy, in patients with atopic dermatitis (AD).

Conditions

  • Atopic Eczema/Dermatitis (Non-Specific)

Interventions

DRUG

crisaborole (2%) ointment

twice daily application on one forearm for 4 weeks (randomised site allocation)

DRUG

betamethasone valerate 0.1% cream

twice daily application on one forearm for 4 weeks (randomised site allocation)

Sponsors & Collaborators

  • University of Sheffield

    collaborator OTHER

  • Sheffield Teaching Hospitals NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Michael J Cork, MB.ChB · The University of Sheffield & Sheffield Teaching Hospitals NHS FT

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-20
Primary Completion
2021-09-30
Completion
2021-09-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04194814 on ClinicalTrials.gov