A Comparison of 000-0551 Lotion Versus Vehicle Lotion in Subjects With Plaque Psoriasis (Study -304)
- Conditions
- Plaque Psoriasis
- Interventions
- Drug: 000-0551 LotionDrug: Vehicle Lotion
- Registration Number
- NCT01871402
- Lead Sponsor
- Therapeutics, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 221
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Arm 000-0551 Lotion Topical lotion, applied twice daily Vehicle Arm Vehicle Lotion Topical lotion, applied twice daily
- Primary Outcome Measures
Name Time Method Proportion of Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA) Day 15 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
Name Time Method Proportion of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) Day 15 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).
Trial Locations
- Locations (10)
Oregon Medical Research Center, PC
🇺🇸Portland, Oregon, United States
Wilmington Dermatology Center
🇺🇸Wilmington, North Carolina, United States
UCSD Dermatology
🇺🇸San Diego, California, United States
Center for Dermatology Clinical Research, Inc.
🇺🇸Fremont, California, United States
Clinical Partners, LLC
🇺🇸Johnston, Rhode Island, United States
Minnesota Clinical Study Center
🇺🇸Fridley, Minnesota, United States
Altman Dermatology Associates
🇺🇸Arlington Heights, Illinois, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Research Across America
🇺🇸Dallas, Texas, United States
Virginia Clinical Research, Inc.
🇺🇸Norfolk, Virginia, United States