NCT03233529

Crisaborole Ointment 2% Skin Biomarker Biopsy Study in Atopic Dermatitis

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED STUDY, TO CHARACTERIZE THE MECHANISM OF ACTION OF CRISABOROLE OINTMENT 2%, BY EVALUATION OF EFFICACY AND CHANGES IN SKIN BIOMARKERS, IN ADULT SUBJECTS WITH MILD TO MODERATE ATOPIC DERMATITIS, WITH A 4 WEEK OPEN-LABEL EXTENSION

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being conducted to characterize the mechanism of action of crisaborole ointment 2%, by evaluation of efficacy and changes in key skin biomarkers in atopic dermatitis (AD) lesions treated with crisaborole ointment 2% over vehicle, in subjects with mild to moderate AD. Two identified AD skin lesions for each subject will be treated for the first 15 days, one with crisaborole ointment 2% and one with vehicle, in a blinded manner, and biopsies for biomarker analysis will be performed on the lesions. Following completion of the blinded treatment period, subjects will start the 28 day open label period during which all AD affected skin lesions will be treated with crisaborole ointment 2% twice daily.

Conditions

• Dermatitis, Atopic

Interventions

Type	Name	Description
DRUG	Crisaborole ointment 2% BID	Crisaborole ointment 2% BID for 15 days (double blind); additional 28 days (open label)
DRUG	Placebo ointment (vehicle)	Placebo ointment (vehicle) BID for 15 days (double blind)

Timeline

• Start date: 2017-07-31
• Primary completion: 2018-05-04
• Completion: 2018-05-04
• First posted: 2017-07-28
• Last updated: 2019-08-13
• Results posted: 2019-08-13

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study