At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of atopic dermatitis according to UK working party diagnostic criteria
- ✓Age 18-65 years at baseline
- ✓Able to read, understand English, and provide informed consent
- ✓Willing to sign informed consent
- ✕Known allergy or hypersensitivity to any excipients of the trial preparations
- ✕Skin features obstructing test areas: acne, suntan, birthmarks, multiple nevi, tattoos, blemishes, or dense body hair
- ✕Eczema severity at treatment sites not clear (score ≥1 on investigator static global assessment); test sites must be clear at baseline
- ✕Use of any topical product on test areas within 7 days prior to baseline, including cosmetics and sunscreen (permitted outside test areas)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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Matched to this trial by ClinicalIndexfrom reputable biotech & medical press.
Validation of a Novel Composite of Skin Biomarkers as a Primary Outcome Measure for Evaluating the Safety of Treatments for Atopic Dermatitis: a Randomized Controlled Trial (Phase 2) Comparing the Effects of Crisaborole 2% Ointment to Betamethasone Valerate 0.1% Cream on Skin Structure and Function in Participants With Atopic Dermatitis.
In Brief
A Phase 2 clinical trial evaluating crisaborole (2%) ointment and betamethasone valerate 0.1% cream for Atopic Eczema/Dermatitis (Non-Specific). Completed, enrolled 37 participants across 1 site.
Detailed 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).
Study Details
Timeline
Interventions
twice daily application on one forearm for 4 weeks (randomised site allocation)
twice daily application on one forearm for 4 weeks (randomised site allocation)