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

Therapeutics, Inc.

Status and phase

Completed

Phase 2

Conditions

Psoriasis

Plaque Psoriasis

Treatments

Drug: 122-0551

Drug: Vehicle

Study type

Interventional

Funder types

Industry

Identifiers

NCT01700985

122-0551-203

Details and patient eligibility

About

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.

Enrollment

44 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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