A Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis (Study 306)
This trial has been completed.
|Treatments||122-0551 foam, vehicle foam|
|Start date||January 2015|
|End date||September 2015|
|Trial size||151 participants|
|Trial identifier||NCT02368210, 122-0551-306|
This Phase 3 study (Study 306) has been designed to determine and compare the efficacy and safety of 122-0551 Foam and Vehicle Foam applied twice daily for two weeks in subjects with plaque psoriasis.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Fremont, CA||Center for Dermatology Clinical Research||completed|
|Miami, FL||International Dermatology Research, Inc.||completed|
|Arlington Heights, IL||Altman Dermatology Associates||completed|
|Fridley, MN||Minnesota Clinical Study Center||completed|
|Albuquerque, NM||Academic Dermatology Associates||completed|
|Knoxville, TN||Dermatology Associates of Knoxville||completed|
|Houston, TX||The Center for Skin Research||completed|
|Norfolk, VA||Virginia Clinical Research, Inc.||completed|
|Intervention model||parallel assignment|
122-0511 Foam, topically applied twice daily
Vehicle Foam, topically applied twice daily
Proportion of subjects rated a "treatment success" based on the Investigator's Global Assessment (IGA)
time frame: Day 15
Proportion of subjects rated a "treatment success" for each of the clinical signs of psoriasis (scaling, erythema and plaque elevation)
time frame: Day 15
All participants at least 18 years old.
- Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 2% and no more than 12% affected body surface area.
- Subject has an Investigator's Global Assessment (IGA) score of at least three (moderate) at study start.
- If subject is a woman of childbearing potential, she must have a negative urine pregnancy test and agree to use an effective form of birth control for the duration of the study.
- Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
- Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis.
- Subject has a physical condition which, in the investigator's opinion, might impair evaluation of plaque psoriasis, or which exposes the subject to an unacceptable risk by study participation.
- Subject has used any phototherapy (including laser), photo-chemotherapy or other forms of photo based therapy for the treatment of their psoriasis within 30 days prior to study start.
- Subject has used any systemic methotrexate, retinoids, systemic corticosteroids [including intralesional, intra-articular, and intramuscular corticosteroids], cyclosporine or analogous products within 90 days prior to study start.
- Subject has used any systemic biologic therapy (i.e., FDA-approved or experimental therapy) within five half-lives of the biologic prior to study start.
- Subject had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to study start or is intending to have such exposure during the study.
|Official title||A Multicenter, Randomized, Double-Blind, Parallel Group Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis (Study 306)|
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