Crisaborole for Chinese and Japanese Subjects (≥2 Years of Age) With Mild to Moderate Atopic Dermatitis

Pfizer

Status and phase: Completed; Phase 3

Conditions: Atopic Dermatitis

Treatments: Drug: Crisaborole Ointment; Drug: Crisaborole Placebo Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT04360187

C3291032

Details and patient eligibility

About

This study is a phase 3, randomized, double blind and vehicle study to evaluate the efficacy and safety of Crisaborole ointment, 2% in Chinese and Japanese subjects with mild to moderate atopic dermatitis involving at least 5% treatable BSA. Eligible subjects will be randomized in a 2:1 ratio to one of 2 treatment groups (Crisaborole BID, Vehicle BID, respectively).

Enrollment: 391 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

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) or clinically significant physical examination finding at Screening that in the PI's or designee's opinion may interfere with study objectives.
• Has participated in a previous crisaborole clinical study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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391 participants in 2 patient groups, including a placebo group

Crisaborole ointment

Experimental group

Description:

Crisaborole ointment application twice daily for 28 days

Treatment:

Drug: Crisaborole Ointment

Crisaborole Placebo Vehicle

Placebo Comparator group

Description:

Vehicle Ointment application twice daily for 28 days

Treatment:

Drug: Crisaborole Placebo Vehicle