Psoriasis Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

222

Study ID:

NCT01882647

Recruitment Status:

Completed

Sponsor:

Therapeutics, Inc.

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There is 1 Location for this study

See Locations Near You

Total Skin and Beauty Dermatology Center, PC
Birmingham Alabama, , United States
MOORE Clinical Research, Inc.
Brandon Florida, , United States
Florida Academic Dermatology Center
Miami Florida, , United States
Park Avenue Dermatology, PA
Orange Park Florida, , United States
The Indiana Clinical Trials Center, PC
Plainfield Indiana, , United States
Hamzavi Dermatology
Fort Gratiot Michigan, , United States
The Psoriasis Treatment Center of Central New Jersey
East Windsor New Jersey, , United States
Academic Dermatology Associates
Albuquerque New Mexico, 87106, United States
Academic Dermatology Associates
Albuquerque New Mexico, , United States
Arlington Research Center, Inc.
Arlington Texas, , United States
DermResearch, Inc.
Austin Texas, , United States

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

222

Study ID:

NCT01882647

Recruitment Status:

Completed

Sponsor:


Therapeutics, Inc.

How clear is this clinincal trial information?

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