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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

Last updated on July 24, 2019

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Study Location
Medical Corporation Heishinkai OPHAC Hospital
Osaka-shi, Osaka, 532-0003 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Atopic Dermatitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
2 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.

NCT03954158
Cheladv74
Recruiting
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

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