Clinical trial NCT01871402: A Comparison of 000-0551 Lotion Versus Vehicle Lotion in Subjects With Plaque Psoriasis (Study -304)
Official title: A Multicenter, Randomized, Double-Blind, Parallel Group Comparison of 000-0551 Lotion Versus Vehicle Lotion in Subjects With Plaque Psoriasis (Study -304)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plaque Psoriasis
Keywords: psoriasis
lotion
investigator's global assessment
Lead sponsor: Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-06
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Proportion of Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA)
timeFrame: Day 15
Secondary outcomes:
measure: Proportion of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)
timeFrame: Day 15
Other outcomes:
measure: Proportion of Subjects With IGA "Treatment Success" at Day 8
timeFrame: Day 8
measure: Proportion of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis at Day 8
timeFrame: Day 8
measure: Change From Baseline in Pruritus Score at Day 15
timeFrame: Baseline and Day 15
measure: Change in % Body Surface Area (BSA) With Active Psoriasis at Days 8 and 15
timeFrame: Baseline, Day 8 and Day 15
Locations:
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research, Inc.
state: California
city: San Diego
country: United States
facility: UCSD Dermatology
state: California
city: Arlington Heights
country: United States
facility: Altman Dermatology Associates
state: Illinois
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Wilmington
country: United States
facility: Wilmington Dermatology Center
state: North Carolina
city: Portland
country: United States
facility: Oregon Medical Research Center, PC
state: Oregon
city: Johnston
country: United States
facility: Clinical Partners, LLC
state: Rhode Island
city: Dallas
country: United States
facility: Research Across America
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
Study officials:
affiliation: Therapeutics, Inc.
name: Syd Dromgoole, Ph.D.
role: STUDY_DIRECTOR
References: