Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
56 participants
INTERVENTIONAL
2007-07-31
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Receive between 22 and 29 days of Cutivate lotion treatment
Fluticasone propionate 0.05% lotion
Daily applications
Interventions
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Fluticasone propionate 0.05% lotion
Daily applications
Eligibility Criteria
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Inclusion Criteria
* Subjects diagnosed with Atopic Dermatitis (AD) and have ≥35% of Body Surface Area
* Subjects meet protocol specific AD signs and symptom severity score
Exclusion Criteria
* Subjects with clinically significant systemic disease
* Subjects who require treatment with systemic or topical retinoids during the study
* Subjects who have been treated with various chronic therapies identified in the protocol
* Subjects who have received other investigational drug treatment within 30 days prior to study entry
3 Months
12 Months
ALL
No
Sponsors
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Fougera Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Alan Fleischer Jr., M.D.
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Lawrence F. Eichenfield, MD
Role: PRINCIPAL_INVESTIGATOR
Rady Children's Hospital, San Diego
Elizabeth Connelly, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Craig L. Leonardi, MD
Role: PRINCIPAL_INVESTIGATOR
Central Dermatology
Lawrence Parish, MD
Role: PRINCIPAL_INVESTIGATOR
Paddington Testing Company, Inc
Adelaide A Hebert, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Sharon Raimer, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas Medical Branch, Galveston
Kenneth E. Bloom, MD
Role: PRINCIPAL_INVESTIGATOR
Dermatology Center for Children and Young Adults
David L Kaplan, MD
Role: PRINCIPAL_INVESTIGATOR
Adult & Pediatric Dermatology
Stephen W. Shewmake, M.D.
Role: PRINCIPAL_INVESTIGATOR
Centre for Health Care Medical Associates
Locations
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Centre for Health Care Medical Associates
Poway, California, United States
Rady Children's Hospital, San Diego
San Diego, California, United States
University of Miami, Dept. of Dermatology
Miami, Florida, United States
Adult & Pediatric Dermatology
Overland Park, Kansas, United States
Dermatology Center for Children and Young Adults
Eagan, Minnesota, United States
Central Dermatology
St Louis, Missouri, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Paddington Testing Company, Inc
Philadelphia, Pennsylvania, United States
University of Texas Medical Branch
Galveston, Texas, United States
University of Texas Health Science Center
Houston, Texas, United States
Countries
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Other Identifiers
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ALT 0434-01-01
Identifier Type: -
Identifier Source: org_study_id
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