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

Pfizer

Status and phase

Terminated

Phase 3

Conditions

Atopic Dermatitis

Treatments

Drug: Crisaborole 2%

Study type

Interventional

Funder types

Industry

Identifiers

NCT04498403

C3291027

Details and patient eligibility

About

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).

Enrollment

40 patients

Sex

All

Ages

7+ months old

Volunteers

No Healthy Volunteers

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.