Efficacy and Safety of AN2898 and AN2728 Topical Ointments to Treat Mild-to-Moderate Atopic Dermatitis
NCT ID: NCT01301508
Last Updated: 2019-02-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
46 participants
INTERVENTIONAL
2011-05-31
2011-11-11
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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AN2898 ointment, 1%, vs. ointment vehicle
AN2898 ointment applied twice daily for 6 weeks to one target lesion, and AN2898 ointment vehicle applied twice daily for 6 weeks to a second target lesion.
Treatments will be randomly assigned to target lesions A and B.
AN2898 ointment, 1%
AN2898 ointment, 1%, applied twice daily for 6 weeks
AN2898 ointment vehicle
AN2898 ointment vehicle applied twice daily for 6 weeks
AN2728 ointment, 2%, vs. ointment vehicle
AN2728 ointment applied twice daily for 6 weeks to one target lesion, and AN2728 ointment vehicle applied twice daily for 6 weeks to a second target lesion.
Treatments will be randomly assigned to target lesions A and B.
AN2728 ointment, 2%
AN2728 ointment, 2%, applied twice daily for 6 weeks
AN2728 ointment vehicle
AN2728 ointment vehicle applied twice daily for 6 weeks
Interventions
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AN2728 ointment, 2%
AN2728 ointment, 2%, applied twice daily for 6 weeks
AN2898 ointment, 1%
AN2898 ointment, 1%, applied twice daily for 6 weeks
AN2898 ointment vehicle
AN2898 ointment vehicle applied twice daily for 6 weeks
AN2728 ointment vehicle
AN2728 ointment vehicle applied twice daily for 6 weeks
Eligibility Criteria
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Inclusion Criteria
* Total body surface area (BSA) of atopic dermatitis involvement ≤35%, excluding involvement of the face, scalp, and groin
* Presence of two (2) comparable target lesions
* Willing and able to apply study medications as directed, comply with study instructions, and commit to attending all visits
* Females of childbearing potential must use at least one highly effective method of birth control. Males with partners of childbearing potential should inform them of their participation in this clinical study and use highly effective methods of birth control during the study.
Exclusion Criteria
* Active or potentially recurrent dermatologic condition other than atopic dermatitis in the target lesion area that may confound evaluation
* Significant confounding conditions as assessed by study doctor
* History or evidence of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis)
* Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
* Pregnancy or lactation
18 Years
75 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
Kogarah, New South Wales, Australia
Anacor Investigational Site
Brisbane, Queensland, Australia
Anacor Investigational Site
Woolloongabba, Queensland, Australia
Anacor Investigational Site
Adelaide, South Australia, Australia
Anacor Investigational Site
Box Hill, Victoria, Australia
Anacor Investigational Site
Carlton, Victoria, Australia
Anacor Investigational Site
Clayton, Victoria, Australia
Anacor Investigational Site
Fitzroy, Victoria, Australia
Anacor Investigational Site
Parkville, Victoria, Australia
Anacor Investigational Site
Fremantle, Western Australia, Australia
Anacor Investigational Site
Nedlands, Western Australia, Australia
Anacor Investigational Site
Subiaco, Western Australia, Australia
Anacor Investigational Site
Victoria Park, Western Australia, Australia
Countries
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References
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Murrell DF, Gebauer K, Spelman L, Zane LT. Crisaborole Topical Ointment, 2% in Adults With Atopic Dermatitis: A Phase 2a, Vehicle-Controlled, Proof-of-Concept Study. J Drugs Dermatol. 2015 Oct;14(10):1108-12.
Other Identifiers
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C3471001
Identifier Type: OTHER
Identifier Source: secondary_id
AN2898-AD-202
Identifier Type: -
Identifier Source: org_study_id
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