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

Therapeutics, Inc.

Status and phase

Completed

Phase 3

Conditions

Plaque Psoriasis

Treatments

Drug: 000-0551 Lotion

Drug: Vehicle Lotion

Study type

Interventional

Funder types

Industry

Identifiers

NCT01882647

000-0551-305

Details and patient eligibility

About

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.

Enrollment

222 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.