At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 620 enrolled
Drug / intervention
Crisaborole 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 3, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Maintenance Treatment and Flare Reduction With Crisaborole Ointment, 2%, Once Daily Over 52 Weeks in Pediatric and Adult Participants (Ages 3 Months and Older) With Mild-to-Moderate Atopic Dermatitis, Who Responded to Twice Daily Crisaborole Ointment, 2%, Treatment
In Brief
A Phase 3 clinical trial evaluating Crisaborole 2% and Vehicle for Atopic Dermatitis. Completed, enrolled 620 participants across 44 sites in 6 countries.
Detailed Summary
This study will evaluate crisaborole therapy once daily (QD) as a long-term topical maintenance therapy for the reduction of flare in responders to crisaborole twice daily (BID) treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtopic Dermatitis
CountriesAustralia, Canada, China, Israel, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedJul 2019
Enrollment StartSep 2019
Primary CompletionJan 2022
TodayJul 2026
First PostedJul 31, 2019
Enrollment StartSep 12, 2019
Primary CompletionJan 19, 2022
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 6.9 years ago
Interventions
Crisaborole 2%drug
Crisaborole ointment 2%
Vehicledrug
Vehicle ointment