Overview

A Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis (Study 306)

Status:
Completed
Trial end date:
2017-02-01
Target enrollment:
0
Participant gender:
All
Summary
This Phase 3 study (Study 306) 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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Therapeutics, Inc.
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 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.

- 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.