A Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis (Study 306)



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:11/28/2018
Start Date:January 2015
End Date:February 2017

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A Multicenter, Randomized, Double-Blind, Parallel Group Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis (Study 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.


Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.
We found this trial at
8
sites
Fridley, Minnesota 55432
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Albuquerque, New Mexico 87106
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Albuquerque, NM
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Arlington Heights, Illinois 60005
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Arlington Heights, IL
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Fremont, California 94538
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Fremont, CA
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Houston, Texas 77056
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Houston, TX
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Knoxville, Tennessee 37917
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Knoxville, TN
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Miami, FL
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Norfolk, Virginia 23507
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Norfolk, VA
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