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



Status:Recruiting
Conditions:Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:August 2012
Contact:Kathy Hormel
Email:khormel@anacor.com
Phone:+001 650-543-7623

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A Multicenter, Randomized, Double-Blind, Four-Week, Bilateral Study of the Safety and Efficacy of Two Concentrations of AN2728 Ointment Administered Once or Twice a Day in Adolescents With Atopic Dermatitis


The purpose of this study is to determine the safety and efficacy of AN2728 Topical
Ointment, 2% and 0.5%, administered once a day (QD) or twice a day (BID), in the treatment
of adolescents with atopic dermatitis (AD)


Inclusion Criteria:

- 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:

- 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
We found this trial at
11
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Salt Lake City, Utah
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Albuquerque, New Mexico
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Detroit, Michigan
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Harrisonburg, Virginia 22801
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High Point, North Carolina 27262
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Knoxville, Tennessee
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Los Angeles, California 90045
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Lousiville, Kentucky
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Lousiville, KY
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Miami, FL
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Portland, Oregon 97223
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Stony Brook, New York 11790
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Stony Brook, NY
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