drugset / Trial / NCT03539601

A Study of Crisaborole Ointment 2%; Crisaborole Vehicle; TCS and TCI in Subjects Aged ≥ 2 Years, With Mild-moderate AD

NCT03539601

Phase 4 Terminated 237 enrolled Pfizer
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This 4-week study will evaluate the safety and efficacy of crisaborole ointment 2%; crisaborole vehicle; topical corticosteroid and topical calcineurin inhibitor, applied twice daily (BID) in subjects who are at least 2 years of age with mild-moderate AD. A Sub-Study of Optical Coherence Tomography and Biomarkers in Subjects ages 2 to \<18 years old, with Mild to Moderate Atopic Dermatitis, treated with Crisaborole Ointment, 2% or Crisaborole Vehicle Ointment or Hydrocortisone Butyrate 0.1% Cream applied BID will also be conducted at select sites.

Timeline

Start
2018-04-27
Primary completion
2020-12-11
Completion
2020-12-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Crisaborole Small molecule 2 % Topical
Comparator Hydrocortisone Butyrate Unknown 0.1 % Topical
Comparator Pimecrolimus Small molecule 1 % Topical

Indications