A Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis
Status: | Completed |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/10/2018 |
Start Date: | January 2015 |
End Date: | February 2017 |
A Multicenter, Randomized, Double-Blind, Parallel Group Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis
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.
122-0551 Foam and Vehicle Foam applied twice daily for two weeks in subjects with plaque
psoriasis.
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.
We found this trial at
9
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