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

A PHASE 3, MULTICENTER, OPEN-LABEL STUDY OF THE LONG-TERM SAFETY OF CRISABOROLE OINTMENT, 2% IN JAPANESE PEDIATRIC AND ADULT PARTICIPANTS WITH MILD TO MODERATE ATOPIC DERMATITIS

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2021-001266-38-Outside-EU/EEA
Enrollment
Unknown
Registered
2021-06-09
Start date
Unknown
Completion date
Unknown
Last updated
2021-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic dermatitis

Interventions

Product Name: Crisaborole Product Code: PF-06930164 Pharmaceutical Form: Ointment INN or Proposed INN: CRISABOROLE CAS Number: 906673-24-3 Concentration unit: % percent Concentration type: equal Conce

Sponsors

Pfizer Inc
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range 32

Exclusion criteria

Exclusion criteria: Has other medical or psychiatric condition(s) 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 judgement, make the participant inappropriate for the study.

Design outcomes

Primary

MeasureTime frame
Main Objective: To study the safety of crisaborole ointment, 2% applied BID in Japanese pediatric and adult participants with mild to moderate Atopic Dermatitis (AD);Secondary Objective: Not Applicable;Primary end point(s): Incidence of Treatment Emergent Adverse Events and Serious Adverse Events Over 56 Weeks;Timepoint(s) of evaluation of this end point: 56 weeks—

Secondary

MeasureTime frame
Secondary end point(s): Not Applicable;Timepoint(s) of evaluation of this end point: Not Applicable—

Countries

Japan

Contacts

Public ContactClinicalTrials.gov Call Center

Pfizer Inc.

ClinicalTrials.gov_Inquiries@Pfizer.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026