At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 32 enrolled
Drug / intervention
Crisaborole ointment 2% +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1, Single-center, Randomized, Vehicle-controlled, Parallel-cohort Study Of Crisaborole Ointment 2% To Evaluate The Skin Irritation Potential In Adult Japanese Healthy Subjects, And To Evaluate The Safety, Tolerability And Pharmacokinetics In Adult Japanese Subjects With Mild To Moderate Atopic Dermatitis
In Brief
A Phase 1 clinical trial evaluating Crisaborole ointment 2% and Vehicle for Healthy and Atopic Dermatitis. Completed, enrolled 32 participants across 1 site.
Detailed Summary
This is a Phase 1 parallel-cohort study of crisaborole ointment 2% to evaluate the skin irritation potential in adult Japanese healthy subjects in Cohort 1, and to evaluate the safety, tolerability and PK in adult Japanese subjects with mild to moderate AD in Cohort 2.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy, Atopic Dermatitis
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedAug 2017
Enrollment StartSep 2017
Primary CompletionNov 2017
TodayJul 2026
First PostedAug 24, 2017
Enrollment StartSep 13, 2017
Primary CompletionNov 27, 2017
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 8.9 years ago
Interventions
Crisaborole ointment 2%drug
Crisaborole ointment 2%
Vehicledrug
Vehicle