CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 137 enrolled
Drug / intervention
Crisaborole ointment 2%drug
Likely dose
Crisaborole ointment 2% applied twice dailyAI-extracted
Key inclusion· 2
  • ✓Age ≥3 months at screening and <24 months at baseline/Day 1
  • ✓Diagnosed with atopic dermatitis
Key exclusion· 1
  • ✕Any clinically significant dermatological condition or disease other than AD, including active or potentially recurrent non-AD dermatological conditions that overlap with AD (e.g., Netherton Syndrome)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03356977
NCT03356977Phase 4Completed
CompareCT.gov

A PHASE 4, MULTICENTER, OPEN-LABEL SAFETY STUDY OF CRISABOROLE OINTMENT 2% IN CHILDREN AGED 3 MONTHS TO LESS THAN 24 MONTHS WITH MILD TO MODERATE ATOPIC DERMATITIS

Pfizer·interventional·Posted Nov 29, 2017·Updated Oct 10, 2019

In Brief

A Phase 4 clinical trial evaluating Crisaborole ointment 2% for Atopic Dermatitis. Completed, enrolled 137 participants across 32 sites in 3 countries.

Detailed Summary

This 4-week study will evaluate the safety, pharmacokinetics (PK), and efficacy of crisaborole ointment 2%, applied twice daily (BID) in subjects who are 3 months to less than 24 months of age with mild-to-moderate AD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtopic Dermatitis
CountriesAustralia, Canada, United States
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedNov 29, 2017
Enrollment StartJan 16, 2018
Primary CompletionApr 12, 2019
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 8.6 years ago

Interventions

Crisaborole ointment 2%drug

Applied BID