Overview

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

Status:
Terminated

Trial end date:
2020-12-11

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Pfizer

Treatments:

Calcineurin Inhibitors
Cortisol succinate
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone-17-butyrate
Pimecrolimus

Criteria

Inclusion Criteria:

Is male or female 2 years and older at the Screening visit/time of informed consent/assent
diagnosed with mild-moderate AD (according to the criteria of Hanifin and Rajka), of at
least 5% BSA.

Exclusion Criteria:

Has any clinically significant medical disorder, condition, or disease (including active or
potentially recurrent non AD dermatological conditions and known genetic dermatological
conditions that overlap with AD, such as Netherton syndrome.

Subjects in Cohort 1 are excluded if they have a contraindication for treatment with
hydrocortisone butyrate cream 0.1%

Subjects in Cohort 2 are excluded if they have a contraindication for treatment with
pimecrolimus cream, 1%