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Efficacy and Safety of AN2728 Topical Ointment to Treat Adolescents With Atopic Dermatitis

Last updated on February 20, 2019

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Study Location
Anacor Investigational Site
Fremont, California, 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)

- Total body surface area (BSA) of atopic dermatitis involvement ≤35%

- Presence of two comparable target lesions

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

- Females of childbearing potential must use a highly effective method of birth control.
Males with partners of childbearing potential should inform them of their
participation in this clinical study and use a highly effective method of birth
control during the study.

- 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 in
the target lesion area 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

NCT01602341
Pfizer
Completed
Efficacy and Safety of AN2728 Topical Ointment to Treat Adolescents With Atopic Dermatitis

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