At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 391 enrolled
Drug / intervention
Crisaborole Ointment +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 3, MULTICENTER, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF CRISABOROLE OINTMENT, 2% IN CHINESE AND JAPANESE PEDIATRIC AND ADULT SUBJECTS (AGES 2 YEARS AND OLDER) WITH MILD TO MODERATE ATOPIC DERMATITIS
In Brief
A Phase 3 clinical trial evaluating Crisaborole Ointment and Crisaborole Placebo Vehicle for Atopic Dermatitis. Completed, enrolled 391 participants across 39 sites in 3 countries.
Detailed Summary
This study is a phase 3, randomized, double blind and vehicle study to evaluate the efficacy and safety of Crisaborole ointment, 2% in Chinese and Japanese subjects with mild to moderate atopic dermatitis involving at least 5% treatable BSA. Eligible subjects will be randomized in a 2:1 ratio to one of 2 treatment groups (Crisaborole BID, Vehicle BID, respectively).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtopic Dermatitis
CountriesChina, Japan, South Korea
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedApr 2020
Enrollment StartJul 2020
Primary CompletionSep 2021
TodayJul 2026
First PostedApr 24, 2020
Enrollment StartJul 27, 2020
Primary CompletionSep 8, 2021
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 6.2 years ago
Interventions
Crisaborole Ointmentdrug
Crisaborole ointment 2%
Crisaborole Placebo Vehicledrug
Placebo for crisaborole ointment