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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Plaque Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active Arm

122-0551 Foam, topically applied twice daily for two weeks

Group Type EXPERIMENTAL

122-0551 Foam

Intervention Type DRUG

122-0551 Foam applied twice daily to treat psoriasis

Vehicle Arm

Vehicle Foam, topically applied twice daily for two weeks

Group Type PLACEBO_COMPARATOR

Vehicle Foam

Intervention Type DRUG

Vehicle Foam applied twice daily to treat psoriasis

Interventions

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122-0551 Foam

122-0551 Foam applied twice daily to treat psoriasis

Intervention Type DRUG

Vehicle Foam

Vehicle Foam applied twice daily to treat psoriasis

Intervention Type DRUG

Eligibility Criteria

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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 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No