A Study Comparing Tazarotene Cream 0.05% to TAZORAC® (Tazarotene) Cream 0.05% and Both to a Placebo Control in the Treatment of Plaque Psoriasis
NCT ID: NCT02886702
Last Updated: 2018-08-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
855 participants
INTERVENTIONAL
2016-09-19
2017-08-02
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
DOUBLE
Study Groups
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Test
Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.)
Tazarotene Cream 0.05%
Tazarotene Cream 0.05% to cover only the lesions with a thin film.
Reference
TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.)
TAZORAC® (tazarotene) Cream 0.05%
TAZORAC® (tazarotene) Cream 0.05% to cover only the lesions with a thin film.
Placebo
Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
Placebo
Placebo (vehicle of the test product) to cover only the lesions with a thin film.
Interventions
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Tazarotene Cream 0.05%
Tazarotene Cream 0.05% to cover only the lesions with a thin film.
TAZORAC® (tazarotene) Cream 0.05%
TAZORAC® (tazarotene) Cream 0.05% to cover only the lesions with a thin film.
Placebo
Placebo (vehicle of the test product) to cover only the lesions with a thin film.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have a minimum plaque elevation at the target lesion site of at least moderate severity (grade ≥ 3 on the Psoriasis Area Severity Index \[PASI\]). The most severe lesion at baseline should be identified as the target lesion
* Have an Investigator's Global Assessment (IGA) of disease severity of at least moderate (score ≥ 3) as an overall assessment of all lesions to be treated.
Exclusion Criteria
* Have a current diagnosis of unstable forms of psoriasis in the treatment area, including pustular, guttate, exfoliative or erythrodermic psoriasis
* Have a history of psoriasis unresponsive to topical treatments
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 Investigational Site
Phoenix, Arizona, United States
Fougera Investigational Site
Hot Springs, Arkansas, United States
Fougera Investigational Site
Anaheim, California, United States
Fougera Investigational Site
North Hollywood, California, United States
Fougera Investigational Site
San Diego, California, United States
Fougera Investigational Site
San Ramon, California, United States
Fougera Investigational Site
Brandon, Florida, United States
Fougera Investigational Site
Coral Gables, Florida, United States
Fougera Investigational Site
Hialeah, Florida, United States
Fougera Investigational Site
Miami, Florida, United States
Fougera Investigational Site
Miami, Florida, United States
Fougera Investigational Site
Miami, Florida, United States
Fougera Investigational Site
Miami Gardens, Florida, United States
Fougera Investigational Site
Miramar, Florida, United States
Fougera Investigational Site
Sweetwater, Florida, United States
Fougera Investigational Site
Tampa, Florida, United States
Fougera Investigational Site
West Palm Beach, Florida, United States
Fougera Investigational Site
Macon, Georgia, United States
Fougera Investigational Site
Arlington Heights, Illinois, United States
Fougera Investigational Site
New Albany, Indiana, United States
Fougera Investigational Site
Plainfield, Indiana, United States
Fougera Investigational Site
Louisville, Kentucky, United States
Fougera Investigational Site
Lake Charles, Louisiana, United States
Fougera Investigational Site
Saint Joseph, Missouri, United States
Fougera Investigational Site
Henderson, Nevada, United States
Fougera Investigational Site
High Point, North Carolina, United States
Fougera Investigational Site
Salem, Oregon, United States
Fougera Investigational Site
Hazleton, Pennsylvania, United States
Fougera Investigational Site
Upper Saint Clair, Pennsylvania, United States
Fougera Investigational Site
San Antonio, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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0453
Identifier Type: OTHER
Identifier Source: secondary_id
0453-01-01
Identifier Type: -
Identifier Source: org_study_id
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