A Study to Determine the Efficacy and Safety of 122-0551 in Subjects With Plaque Psoriasis



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:10/27/2018
Start Date:May 2012
End Date:March 2013

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A Double-Blind, Randomized, Single Center, Vehicle-Controlled, Parallel Group Study to Determine the Efficacy and Safety of 122-0551 in Subjects With Plaque Psoriasis Receiving Two Weeks of Treatment

Corticosteroids are one of the mainstays of treatment for subjects with
corticosteroid-responsive dermatoses such as psoriasis. This study has been designed to
determine and compare the efficacy and safety of a formulation of 122-0551 versus the
corresponding Vehicle in subjects with stable plaque psoriasis after twice daily dosing for
14 consecutive days.


Inclusion Criteria:

- Subject has a clinical diagnosis of stable plaque psoriasis

- Subject has an ODS score for the Treatment Area of 3 or 4 at study start

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, photo-chemotherapy or systemic corticosteroid
therapy within 30 days prior to study start

- Subject has used any systemic methotrexate, retinoids, cyclosporine or analogous
products within 90 days prior to study start

- Subject has used any systemic biologic therapy for the treatment of psoriasis within 5
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

- Subject has used topical body (excluding the scalp) psoriasis therapy including coal
tar, anthralin, steroids, retinoids, vitamin D analogs (e.g., Dovonex®) 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., propranolol) or ACE
(e.g., lisinopril) 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
2
sites
Austin, Texas 78759
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San Diego, California 92123
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San Diego, CA
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