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A Study of Crisaborole Ointment 2% in Adult Japanese Healthy Subjects and Adult Japanese Subjects With Mild To Moderate Atopic Dermatitis

Last updated on March 14, 2019

FOR MORE INFORMATION
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.
Healthy, Atopic Dermatitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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Cohort 1

1. Healthy male Japanese subjects who, at the time of screening, are between the ages of
20 and 55 years, inclusive.

2. Healthy skin on which reddening can be easily recognized in the area of the test
fields.

Cohort 2

1. Male or female Japanese subjects aged 20 years to 55 years (inclusive) at the time of
screening, and in generally good health except for AD.

2. Diagnosis of AD based on the criteria of Hanifin and Rajka (1980).

3. Has at least 25% Treatable %BSA on Day 1 (excluding the scalp and designated venous
access areas).

4. Has an 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.
Show details

Cohort 1

1. Subjects who have any visible skin disease at the application site which, in the
opinion of the investigative personnel, will interfere with the evaluation of the test
site reaction.

2. Subjects who have psoriasis and/or active AD/eczema.

3. Subjects who have a history of AD.

4. Subjects who have damaged skin in or around the test sites, including sunburn,
excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous
freckles, or other disfigurations of the test site.

5. Known sensitivity to any of the components of the investigational products.

6. History of the rash to the adhesive plaster, contact dermatitis to metal, or cosmetic
and household articles.

Cohort 2

1. Has any clinically significant medical disorder, condition, disease (including active
or potentially recurrent dermatological conditions other than AD), significant
physical examination or laboratory findings that may interfere with study objectives,
in the Investigator's opinion.

2. Has unstable AD or a consistent requirement for strong to strongest potency topical
corticosteroids to manage AD signs and symptoms.

3. Has a significant active systemic or localized infection, including known actively
infected AD.

4. Has a history or evidence of clinically significant or severe allergies (eg, seasonal,
pet dander, environmental, food) requiring acute or chronic treatment.

5. Has recent or anticipated concomitant use of topical or systemic therapies that might
alter the course of AD.

6. Has a history of recent (within 4 weeks of Day 1) sunbathing, tanning bed use, or
ultraviolet (UV) light B therapy (UVB) or psoralen plus UVA [PUVA]).

7. Has a known sensitivity to any of the components of crisaborole ointment 2%.

8. Pregnant female subjects; breastfeeding female subjects; female subjects of
childbearing potential who are unwilling or unable to use a highly effective method of
contraception as outlined in this protocol for the duration of the study and for at
least 28 days after the last dose of investigational product.

NCT03260595
Pfizer
Completed
A Study of Crisaborole Ointment 2% in Adult Japanese Healthy Subjects and Adult Japanese Subjects With Mild To Moderate Atopic Dermatitis

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[email protected]

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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