Clinical trial NCT02367911: A Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis
Official title: A Multicenter, Randomized, Double-Blind, Parallel Group Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plaque Psoriasis
Lead sponsor: Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2015-02-20
Enrollment: 144
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 122-0551 Foam and Vehicle Foam 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 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.

Primary outcomes:
measure: Percentage of Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA)
timeFrame: Day 15
Secondary outcomes:
measure: 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: Proportion of Subjects With IGA "Treatment Success"
timeFrame: Day 8
measure: Proportion of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)
timeFrame: Day 8
measure: Change From Baseline in Pruritus Score
timeFrame: Day 15
measure: Change in % Body Surface Area (BSA) With Active Psoriasis
timeFrame: Day 8 and Day 15
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Dermatology Center, PC
state: Alabama
city: San Diego
country: United States
facility: UCSD Dermatology
state: California
city: Ormond Beach
country: United States
facility: Leavitt Medical Associates of Florida d/b/a Ameriderm Research
state: Florida
city: Carmel
country: United States
facility: Shideler Clinical Research Center
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center, PC
state: Indiana
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Saint Joseph
country: United States
facility: MediSearch Clinical Trials
state: Missouri
city: High Point
country: United States
facility: Dermatology Consulting Services
state: North Carolina
city: Arlington
country: United States
facility: Arlington Research Center, Inc.
state: Texas
Study officials:
affiliation: Therapeutics, Inc.
name: Anthony Andrasfay
role: STUDY_DIRECTOR
References: