A Comparison of 000-0551 Lotion Versus Vehicle Lotion in Subjects With Plaque Psoriasis (Study -305)
Status: | Completed |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 5/5/2014 |
Start Date: | June 2013 |
End Date: | February 2014 |
A Multicenter, Randomized, Double-Blind, Parallel Group Comparison of 000-0551 Lotion Versus Vehicle Lotion in Subjects With Plaque Psoriasis (Study -305)
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.
000-0551 Lotion and Vehicle Lotion 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 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.
We found this trial at
11
sites
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59 One Mile Road
East Windsor, New Jersey 08520
East Windsor, New Jersey 08520
609-443-4500
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