A Comparison of 188-0551 Spray Versus Vehicle Spray in Subjects With Plaque Psoriasis
NCT ID: NCT03759197
Last Updated: 2020-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
206 participants
INTERVENTIONAL
2018-11-26
2019-08-27
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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Drug: 188-0551 Spray
188-0551 Spray applied topically twice daily to psoriatic lesions within the assigned treatment area for up to four (4) weeks
188-0551 Spray
Topical Spray containing active drug
Vehicle Spray
Vehicle Spray applied topically twice daily to psoriatic lesions within the assigned treatment area for up to four (4) weeks
Vehicle Spray
Topical Spray containing no active drug
Interventions
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188-0551 Spray
Topical Spray containing active drug
Vehicle Spray
Topical Spray containing no active drug
Eligibility Criteria
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Inclusion Criteria
2. Subject has provided written informed consent.
3. Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 2% and no more than 10% body surface area (BSA) (excluding the face, scalp, groin, axillae, and other intertriginous areas).
4. Subject has moderate to severe plaque psoriasis.
5. Subject is willing and able to apply the test article as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
6. Females must be post-menopausal , surgically sterile , or use an effective method of birth control. , Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at the Baseline Visit.
Exclusion Criteria
2. Subject has guttate, pustular, erythrodermic, or other non-plaque forms of psoriasis.
3. Subject has palmar/plantar psoriasis.
4. Subject is pregnant, lactating, or is planning to become pregnant during the study.
5. Subject is currently enrolled in an investigational drug or device study.
6. Subject has been previously enrolled in this study and treated with a test article.
18 Years
ALL
No
Sponsors
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Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Tony Andrasfay
Role: STUDY_DIRECTOR
Therapeutics, Inc.
Locations
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Site 06
Fort Smith, Arkansas, United States
Site 09
Fountain Valley, California, United States
Site 07
Fremont, California, United States
Site 02
Aventura, Florida, United States
Site 04
Brandon, Florida, United States
Site 01
Largo, Florida, United States
Site 05
North Miami Beach, Florida, United States
Site 08
Albany, Indiana, United States
Site 03
Plainfield, Indiana, United States
Site 11
Louisville, Kentucky, United States
Site 12
Metairie, Louisiana, United States
Site 10
Fountain Inn, South Carolina, United States
Countries
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Other Identifiers
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188-0551-305
Identifier Type: -
Identifier Source: org_study_id
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