A Comparison of 000-0551 Lotion Versus Vehicle Lotion in Subjects With Plaque Psoriasis (Study -305)



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:5/5/2014
Start Date:June 2013
End Date:February 2014

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A Multicenter, Randomized, Double-Blind, Parallel Group Comparison of 000-0551 Lotion Versus Vehicle Lotion in Subjects With Plaque Psoriasis (Study -305)

This Phase 3 study has been designed to determine and compare the efficacy and safety of
000-0551 Lotion and Vehicle Lotion 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 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.

- Subject has used topical body (excluding the scalp) psoriasis therapy (including coal
tar, anthralin, steroids, retinoids, vitamin D analogs) within 14 days prior to study
start.

- Subject has used emollients/moisturizers on areas to be treated within four hours
prior to clinical evaluation at study start.

- Subject is currently using lithium or Plaquenil (hydroxychloroquine).

- Subject is currently using a beta-blocking medication (e.g., propanolol) or
angiotensin converting enzyme (ACE) inhibitor at a dose that has not been stabilized.

- Subject is pregnant, lactating, or is planning to become pregnant during the study.

- Subject is currently enrolled in an investigational drug or device study.

- Subject has used an investigational drug or investigational device treatment within
30 days prior to study start.

- Subject has been previously enrolled in this study and treated with a test article.
We found this trial at
11
sites
Birmingham, Alabama 35205
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Birmingham, AL
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59 One Mile Road
East Windsor, New Jersey 08520
609-443-4500
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East Windsor, NJ
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Albuquerque, New Mexico 87106
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Albuquerque, NM
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Albuquerque, New Mexico 87106
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Albuquerque, NM
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Arlington, Texas 76011
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Arlington, TX
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Austin, Texas 78759
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Austin, TX
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Brandon, Florida 33511
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Brandon, FL
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Fort Gratiot, Michigan 48059
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Fort Gratiot, MI
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Miami, FL
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Orange Park, Florida 32073
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Orange Park, FL
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Plainfield, Indiana 46168
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Plainfield, IN
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