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

Pfizer logo

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

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

Trial documents
2

Trial contacts and locations

39

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Data sourced from clinicaltrials.gov

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