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

Completed · Phase 2

Conditions studied: Psoriasis, Plaque Psoriasis

In brief

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.

Key facts

Study ID

NCT01700985

Run by

Therapeutics, Inc.

People needed

44

Starts

2012-05-01

Expected to finish

2013-03-01

Last updated by the study team

2018-10-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Therapeutics Clinical Research — San Diego, California, United States
• DermResearch, Inc. — Austin, Texas, United States

Full record on ClinicalTrials.gov

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