Phase 3
Completed N=222
A Comparison of 000-0551 Lotion Versus Vehicle Lotion in Subjects With Plaque Psoriasis (Study -305)
Source: ClinicalTrials.gov NCT01882647 ↗Enrolled (actual)
222
Serious AEs
0.4%
Results posted
Feb 2017
Primary outcomePrimary: The Percentage of Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA) — 44.5; 7.1 percentage of participants — p=<0.001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA) |
44.5; 7.1 | <0.001 sig |
| SECONDARY The Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) |
59.1; 9.8; 43.6; 10.7; 43.6; 8.0 | <0.001 sig |
Eligibility 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 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.
Data sourced from ClinicalTrials.gov (NCT01882647). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.