CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 37 enrolled
Drug / intervention
crisaborole (2%) ointment +1 moredrug
Likely dose
Crisaborole 2% ointment applied topically twice daily; betamethasone valerate 0.1% cream applied topically twice dailyAI-extracted
Key inclusion· 4
  • 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
Key exclusion· 8
  • 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.

In the news

4 articles

Matched to this trial by ClinicalIndexfrom reputable biotech & medical press.

Search/NCT04194814
NCT04194814Phase 2Completed

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.

Sheffield Teaching Hospitals NHS Foundation Trust·interventional·Posted Dec 11, 2019·Updated Jul 18, 2025

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedDec 11, 2019
Enrollment StartNov 20, 2020
Primary CompletionSep 30, 2021
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 6.6 years ago

Interventions

crisaborole (2%) ointmentdrug

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

betamethasone valerate 0.1% creamdrug

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