Study to Assess Efficacy and Safety of Two Regimens of Crisaborole Ointment 2% in Japanese Participants Aged ≥2 Years With Mild to Moderate Atopic Dermatitis

Pfizer

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: Crisaborole ointment 2%; Drug: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT03954158

C3291028

Details and patient eligibility

About

This is a Phase 2b, multi-center, randomized, double-blind, vehicle-controlled, intraparticipant study to evaluate efficacy and safety of two regimens of crisaborole ointment 2% in Japanese pediatric and adult participants (cohort 1: 12 years and older, cohort 2: 2 to under 12 years old) with mild to moderate Atopic Dermatitis (AD).

Enrollment: 81 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female participants ages; Cohort 1: 12 years and older at the time of consent. Cohort 2: 2 years to under 12 years old at the time of consent.
• Has confrimed clinical diagnosis of active AD according to Hanifin and Rajka criteria and has at least 6 months history prior to screening and has been clinically stable for more than 1 month
• Has at least 1% and no more than 30% BSA at baseline/Day1, excluding scalp, genitals and groin area
• Has a Investigator's static global assessment (ISGA) score of Mild (2) or Moderate (3) on Day 1.

Exclusion criteria

• Has other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
• Participants had previous treatment with any topical or systemic PDE-4 inhibitor.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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81 participants in 2 patient groups

Crisaborole ointment 2% once daily (QD) vs vehicle QD

Experimental group

Description:

intra-participant comparison, treatment will be randomly assigned to target lesion 1 and lesion 2.

Treatment:

Drug: Crisaborole ointment 2%

Drug: Crisaborole ointment 2%

Drug: Vehicle

Drug: Vehicle

Crisaborole ointment 2% twice daily (BID) vs vehicle BID

Experimental group

Description:

Intra-participant comparison, treatment will be randomly assigned to target lesion 1 and lesion 2.

Treatment:

Drug: Crisaborole ointment 2%

Drug: Crisaborole ointment 2%

Drug: Vehicle

Drug: Vehicle