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Safety, Tolerability, and PK of AN2728 in Adolescents With Atopic Dermatitis

Last updated on February 23, 2019

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Study Location
Anacor Investigational Site
Fremont, California, 94538 United States
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
12-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Male or female 12 to 17 years of age, inclusive

- Clinical diagnosis of atopic dermatitis (according to the criteria of Hanifin and
Rajka)

- AD in treatable areas (excludes the scalp and venous access areas) involving

≥10% and ≤35% of the total body surface area(BSA)

- Investigator's Static Global Assessment (ISGA) score of 2 or 3

- Normal or not clinically significant screening laboratory results

- Have adequate venous access to permit repeated PK sampling on Days 1 - 9 through
uninfected skin that has not been treated with study drug; each untreated venous
access area should provide a margin of at least 5 cm radius around the venipuncture
site

- Willing and able to comply with study instructions and commit to attending all visits

- Females must use a highly effective method of birth control.

- Parent/guardian has the ability to understand, agree to and sign the study Informed
Consent Form (ICF) prior to initiation of any protocol-related procedures; subject has
the ability to give assent

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Significant confounding conditions as assessed by study doctor

- Unstable or actively infected AD

- Active or potentially recurrent dermatologic condition other than atopic dermatitis
that may confound evaluation

- History or evidence of allergies requiring acute or chronic treatment (except seasonal
allergic rhinitis)

- Concurrent or recent use of certain topical or systemic medications or phototherapy
without a sufficient washout period

- Treatment for any type of cancer (except squamous cell carcinoma, basal cell
carcinoma, or carcinoma in situ of the skin, curatively treated with cryosurgery or
surgical excision only) within the last 5 years

- Current pregnancy or lactation, or intent to become pregnant during the study

- Known sensitivity to any of the components of the study drug

- Participated in any other trial of an investigational drug or device within 30 days or
participation in a research study concurrent with this study

- Participated in a previous AN2728 clinical study

NCT01652885
Pfizer
Completed
Safety, Tolerability, and PK of AN2728 in Adolescents With Atopic Dermatitis

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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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