Overview

A Study of the Long-Term Safety of Crisaborole Ointment, 2% in Japanese Pediatric and Adult Participants With Mild to Moderate Atopic Dermatitis

Status:
Terminated

Trial end date:
2020-12-18

Target enrollment:
0

Participant gender:
All

Summary

This study is a Phase 3, multicenter, open-label, long-term safety extension study of Studies C3291032 and C3291031 in Japanese pediatric and adult participants with mild to moderate Atopic Dermatitis (AD).

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Pfizer

Criteria

Inclusion Criteria:

- Male or female participants;

- Who were patients with mild to moderate AD aged 2 years old or older and met
eligibility criteria for study C3291032 at the time when entering Study C3291032, and
completed treatment period in Study C3291032 without safety issues. Or

- Who were patients with mild to moderate AD aged 1 months to <24 months and met
eligibility criteria for Study C3291031 at the time when entering Study C3291031, and
completed treatment period in Study C3291031 without safety issues

Exclusion Criteria:

- Has other medical or psychiatric condition including recent (within the past year) or
active suicidal ideation/behavior or laboratory abnormality that may increase the risk
of study participation or, in the investigator's judgment, make the participant
inappropriate for the study.