Efficacy and Safety of AN2728 Topical Ointment to Treat Adolescents With Atopic Dermatitis
NCT ID: NCT01602341
Last Updated: 2017-03-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
86 participants
INTERVENTIONAL
2012-08-31
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AN2728 Topical Ointment, 2% QD vs 0.5% QD
AN2728 Topical Ointment, 2% applied once daily for 29 days to a target lesion, and AN2728 Topical Ointment, 0.5% applied once daily for 29 days to a target lesion
Treatments will be randomly assigned to target lesions A and B.
AN2728 Topical Ointment, 2% QD
AN2728 Topical Ointment, 2% QD
AN2728 Topical Ointment, 0.5% QD
AN2728 Topical Ointment, 0.5% QD
AN2728 Topical Ointment, 2% BID vs 0.5% BID
AN2728 Topical Ointment, 2% applied twice daily for 29 days to a target lesion, and AN2728 Topical Ointment, 0.5% applied twice daily for 29 days to a target lesion.
Treatments will be randomly assigned to target lesions A and B.
AN2728 Topical Ointment, 2% BID
AN2728 Topical Ointment, 2% BID
AN2728 Topical Ointment, 0.5% BID
AN2728 Topical Ointment, 0.5% BID
Interventions
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AN2728 Topical Ointment, 2% QD
AN2728 Topical Ointment, 2% QD
AN2728 Topical Ointment, 0.5% QD
AN2728 Topical Ointment, 0.5% QD
AN2728 Topical Ointment, 2% BID
AN2728 Topical Ointment, 2% BID
AN2728 Topical Ointment, 0.5% BID
AN2728 Topical Ointment, 0.5% BID
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
17 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Anacor Investigational Site
Fremont, California, United States
Anacor Investigational Site
Miami, Florida, United States
Anacor Investigational Site
Lousiville, Kentucky, United States
Anacor Investigational Site
Detroit, Michigan, United States
Anacor Investigational Site
Albuquerque, New Mexico, United States
Anacor Investigational Site
Stony Brook, New York, United States
Anacor Investigational Site
High Point, North Carolina, United States
Anacor Investigational Site
Portland, Oregon, United States
Anacor Investigational Site
Knoxville, Tennessee, United States
Anacor Investigational Site
Salt Lake City, Utah, United States
Anacor Investigational Site
Norfolk, Virginia, United States
Anacor Investigational Site
Phillip, Australian Capital Territory, Australia
Anacor Investigational Site
Kogarah, New South Wales, Australia
Anacor Investigational Site
Wooloongabba, Queensland, Australia
Anacor Investigational Site
Box Hill, Victoria, Australia
Anacor Investigational Site
Parkville, Victoria, Australia
Anacor Investigational Site
Fremantle, Western Australia, Australia
Countries
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Other Identifiers
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AN2728-AD-204
Identifier Type: -
Identifier Source: org_study_id
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