NCT03868098

Different Application Rates of Crisaborole Ointment 2% in Adults With Mild to Moderate Atopic Dermatitis

A Randomized, Double-Blind, Intra-Individual, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Different Application Rates of Topically Applied Crisaborole Ointment 2% in Adult Subjects With Mild to Moderate Atopic Dermatitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Innovaderm Research Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being conducted to evaluate the efficacy and safety of 3 different application rates of topically applied Crisaborole ointment 2% over vehicle in adults with mild to moderate atopic dermatitis (AD). In each subject four application areas will be identified. Each subject will receive 4 treatments: the 3 different application rates of the active treatment and the vehicle. The areas will be randomly assigned to treatment with topical Crisaborole ointment 2% and vehicle, once daily, for 2 weeks, without occlusion.

Conditions

• Dermatitis, Atopic

Interventions

Type	Name	Description
DRUG	Crisaborole 2%	Crisaborole ointment 2% (application rate A, B, C) for 15 days (double blind)
DRUG	Placebo ointment	Placebo ointment (vehicle)

Timeline

• Start date: 2019-05-21
• Primary completion: 2020-11-25
• Completion: 2020-11-25
• First posted: 2019-03-08
• Last updated: 2021-08-24

Locations

1 site across 1 country: Canada