Clinical trial NCT01882647: A Comparison of 000-0551 Lotion Versus Vehicle Lotion in Subjects With Plaque Psoriasis (Study -305)
Official title: A Multicenter, Randomized, Double-Blind, Parallel Group Comparison of 000-0551 Lotion Versus Vehicle Lotion in Subjects With Plaque Psoriasis (Study -305)
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: 2013-06-20
Enrollment: 222
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: The Percentage of Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA)
timeFrame: Day 15
Secondary outcomes:
measure: The Percentage 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: Percentage of Subjects With IGA "Treatment Success" at Day 8
timeFrame: Day 8
measure: Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) at Day 8
timeFrame: Day 8
measure: Change From Baseline in Pruritus Score at Day 15
timeFrame: Baseline and Day 15
measure: Change in Percent Body Surface Area (% BSA) With Active Psoriasis at Day 15
timeFrame: Day 15
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Dermatology Center, PC
state: Alabama
city: Brandon
country: United States
facility: MOORE Clinical Research, Inc.
state: Florida
city: Miami
country: United States
facility: Florida Academic Dermatology Center
state: Florida
city: Orange Park
country: United States
facility: Park Avenue Dermatology, PA
state: Florida
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center, PC
state: Indiana
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: East Windsor
country: United States
facility: The Psoriasis Treatment Center of Central New Jersey
state: New Jersey
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: Arlington
country: United States
facility: Arlington Research Center, Inc.
state: Texas
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
Study officials:
affiliation: Therapeutics, Inc.
name: Syd Dromgoole, Ph.D.
role: STUDY_DIRECTOR
References: