A Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis

Completed · Phase 3

Conditions studied: Plaque Psoriasis

In brief

This Phase 3 study has been designed to determine and compare the efficacy and safety of 122-0551 Foam and Vehicle Foam applied twice daily for two weeks in subjects with plaque psoriasis.

Key facts

Study ID

NCT02367911

Run by

Therapeutics, Inc.

People needed

144

Starts

2015-01-01

Expected to finish

2017-02-01

Last updated by the study team

2018-11-08

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 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.

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 a physical condition which, in the investigator's opinion, might impair evaluation of plaque psoriasis, or which exposes the subject to an unacceptable risk by study participation.
• 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.

Where it is running

• Total Skin and Beauty Dermatology Center, PC — Birmingham, Alabama, United States
• UCSD Dermatology — San Diego, California, United States
• Leavitt Medical Associates of Florida d/b/a Ameriderm Research — Ormond Beach, Florida, United States
• Shideler Clinical Research Center — Carmel, Indiana, United States
• The Indiana Clinical Trials Center, PC — Plainfield, Indiana, United States
• Henry Ford Health System — Detroit, Michigan, United States
• MediSearch Clinical Trials — Saint Joseph, Missouri, United States
• Dermatology Consulting Services — High Point, North Carolina, United States
• Arlington Research Center, Inc. — Arlington, Texas, United States

Full record on ClinicalTrials.gov

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