Back to resultsA Comparison of 000-0551 Lotion Versus Vehicle Lotion in Subjects With Plaque Psoriasis (Study -304)
Primary Purpose
Plaque Psoriasis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
000-0551 Lotion
Vehicle Lotion
Sponsored by
About this trial
This is an interventional treatment trial for Plaque Psoriasis focused on measuring psoriasis, lotion, investigator's global assessment
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.
Sites / Locations
- Center for Dermatology Clinical Research, Inc.
- UCSD Dermatology
- Altman Dermatology Associates
- Henry Ford Health System
- Minnesota Clinical Study Center
- Wilmington Dermatology Center
- Oregon Medical Research Center, PC
- Clinical Partners, LLC
- Research Across America
- Virginia Clinical Research, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active Arm
Vehicle Arm
Arm Description
Topical lotion, applied twice daily
Topical lotion, applied twice daily
Outcomes
Primary Outcome Measures
Proportion of Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA)
The IGA score is a static evaluation of the overall or "average" degree of severity of a subject's disease, taking into account all of the subject's psoriatic lesions. "Treatment success" is defined as a score of 0 or 1 representing "cleared" or "almost cleared" at Day 15 with at least a two grade decrease in severity score relative to Baseline. IGA is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe).
Secondary Outcome Measures
Proportion of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)
A static assessment of the overall or "average" degree of severity of each of three key characteristics present within all of the subject's psoriatic lesions. "Treatment success" is defined as a score of 0 or 1 representing "cleared" or "almost cleared" at Day 15 with at least a two grade decrease in severity score relative to Baseline. Each clinical sign of psoriasis is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01871402
Brief Title
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
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Therapeutics, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
Keywords
psoriasis, lotion, investigator's global assessment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
221 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Arm
Arm Type
Experimental
Arm Description
Topical lotion, applied twice daily
Arm Title
Vehicle Arm
Arm Type
Placebo Comparator
Arm Description
Topical lotion, applied twice daily
Intervention Type
Drug
Intervention Name(s)
000-0551 Lotion
Intervention Type
Drug
Intervention Name(s)
Vehicle Lotion
Primary Outcome Measure Information:
Title
Proportion of Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA)
Description
The IGA score is a static evaluation of the overall or "average" degree of severity of a subject's disease, taking into account all of the subject's psoriatic lesions. "Treatment success" is defined as a score of 0 or 1 representing "cleared" or "almost cleared" at Day 15 with at least a two grade decrease in severity score relative to Baseline. IGA is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe).
Time Frame
Day 15
Secondary Outcome Measure Information:
Title
Proportion of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)
Description
A static assessment of the overall or "average" degree of severity of each of three key characteristics present within all of the subject's psoriatic lesions. "Treatment success" is defined as a score of 0 or 1 representing "cleared" or "almost cleared" at Day 15 with at least a two grade decrease in severity score relative to Baseline. Each clinical sign of psoriasis is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe).
Time Frame
Day 15
Other Pre-specified Outcome Measures:
Title
Proportion of Subjects With IGA "Treatment Success" at Day 8
Description
Interim analysis of IGA. "Treatment success" and IGA as defined in the primary outcome measure.
Time Frame
Day 8
Title
Proportion of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis at Day 8
Description
Interim analysis of clinical signs of psoriasis (scaling, erythema and plaque elevation). "Treatment success" and clinical signs as defined in the secondary outcome measure.
Time Frame
Day 8
Title
Change From Baseline in Pruritus Score at Day 15
Description
Pruritus scale will be used to assess the subjective and multidimensional experience of the subject's pruritus (itching) during the previous two weeks at Baseline and Day 15. Possible scores range from 5 (no pruritus) to 25 (most severe pruritus).
Time Frame
Baseline and Day 15
Title
Change in % Body Surface Area (BSA) With Active Psoriasis at Days 8 and 15
Description
The investigator will use the assumption that 1% BSA is approximately equal to the surface area of the subject's palm and fingers, with the fingers extended yet grouped together, creating a flat oval-like surface area.
Time Frame
Baseline, Day 8 and Day 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syd Dromgoole, Ph.D.
Organizational Affiliation
Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Center for Dermatology Clinical Research, Inc.
City
Fremont
State/Province
California
Country
United States
Facility Name
UCSD Dermatology
City
San Diego
State/Province
California
Country
United States
Facility Name
Altman Dermatology Associates
City
Arlington Heights
State/Province
Illinois
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Minnesota Clinical Study Center
City
Fridley
State/Province
Minnesota
Country
United States
Facility Name
Wilmington Dermatology Center
City
Wilmington
State/Province
North Carolina
Country
United States
Facility Name
Oregon Medical Research Center, PC
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Clinical Partners, LLC
City
Johnston
State/Province
Rhode Island
Country
United States
Facility Name
Research Across America
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Virginia Clinical Research, Inc.
City
Norfolk
State/Province
Virginia
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Comparison of 000-0551 Lotion Versus Vehicle Lotion in Subjects With Plaque Psoriasis (Study -304)
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