Study of 0416 Ointment in the Treatment of Atopic Dermatitis
NCT ID: NCT01053247
Last Updated: 2014-10-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
793 participants
INTERVENTIONAL
2008-01-31
2009-08-31
Brief Summary
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Treatment medication will be administered as follows: Apply a thin layer of ointment to affected skin areas twice daily and rub in gently and completely. Study medication will be applied twice a day, approximately 12 hours apart, for approximately 2 weeks.
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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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Test
Test product that contains the active pharmaceutical ingredient
0416
Topical 0416 test product applied twice daily for 2 weeks
Reference
Reference product that contains active pharmaceutical ingredient
tacrolimus ointment 0.1%
Reference Product for 0416 test product. Apply twice daily for 2 weeks.
Vehicle
Placebo that contains no active pharmaceutical ingredient
Vehicle of 0416 test product
Vehicle of 0416 test product applied twice daily for 2 weeks
Interventions
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0416
Topical 0416 test product applied twice daily for 2 weeks
Vehicle of 0416 test product
Vehicle of 0416 test product applied twice daily for 2 weeks
tacrolimus ointment 0.1%
Reference Product for 0416 test product. Apply twice daily for 2 weeks.
Eligibility Criteria
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Inclusion Criteria
* Good health with the exception of Atopic Dermatitis
* Percent Body Surface Area minimum requirements
Exclusion Criteria
* Subjects who have any systemic or dermatological disorders with the exception of Atopic Dermatitis
18 Years
ALL
No
Sponsors
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Fougera Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Angela C Kaplan
Role: STUDY_DIRECTOR
Fougera Pharmaceuticals Inc.
Locations
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Fougera Pharmaceuticals Inc.
Melville, New York, United States
Countries
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Other Identifiers
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0416
Identifier Type: -
Identifier Source: org_study_id
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