- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00539929
Paired-Comparison Study Evaluating the Efficacy and Safety of E6201 Versus Vehicle for the Treatment of Plaque-Type Psoriasis
February 3, 2017 updated by: Eisai Inc.
Proof of Principle, Randomized, Parallel-Group, Double-Blind, Vehicle-Controlled, Paired-Comparison Study Evaluating the Efficacy and Safety of E6201 Versus Vehicle for the Treatment of Plaque-Type Psoriasis
This is a double-blind, multicenter study to assess the efficacy and safety of E6201 topical administration to pre-identified marker lesions in adult subjects with chronic plaque type psoriasis.
Treatment duration is 8 weeks, followed by a 4-week period without treatment.
Pharmacokinetic samples will be obtained pre-and post treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arkansas
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Hot Springs, Arkansas, United States
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California
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San Diego, California, United States
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Idaho
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Boise, Idaho, United States
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Illinois
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Champaign, Illinois, United States
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Michigan
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Clinton Township, Michigan, United States
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Minnesota
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Fridley, Minnesota, United States
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Nebraska
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Omaha, Nebraska, United States
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New Jersey
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Carlstadt, New Jersey, United States
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Oregon
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Portland, Oregon, United States
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Texas
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Austin, Texas, United States
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College Station, Texas, United States
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Virginia
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Lynchburg, Virginia, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
INCLUSION CRITERIA:
- Males and females 18 years or older with a clinical diagnosis of mild-to-moderate plaque-type psoriasis for ≥12 months prior to screening
- Female participants postmenopausal >1 year or surgically sterile
- Two representative and similar target lesions for the condition, each of 15-25 centimeters squared (cm^2), up to 50 cm^2 in surface area
- Target lesion severity score of 4-8 on a scale of 0 to 12, where, in the opinion of the Investigator, 0 equals no evidence of disease and 12 equals severe induration, erythema, scaling, and pruritus
- Prescription medications, if applicable, for chronic conditions allowed but must be on a stable regimen prior to and during the study; this is also applicable for dietary supplements and over-the-counter (OTC) drugs
- Participants able and willing to give informed consent
EXCLUSION CRITERIA
- Use of any, concomitant, topical treatment for psoriasis, excluding emollients
- Use of any, concomitant, systemic treatment for psoriasis, including ultraviolet radiation (UVR) light
- Evidence of significant hepatic, gastrointestinal, renal, respiratory, endocrine, hematological, neurological, psychiatric, musculoskeletal, rheumatologic, or cardiovascular system abnormalities
- Evidence of any clinically significant deviation from normal with respect to medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), or clinical laboratory determinations. If any participant has an abnormal clinical laboratory test finding that meets specified criteria, that participant will be re-tested by repeated blood draw and clinical laboratory assessment. If the abnormal test finding is confirmed, the participant will be excluded from the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: E6201 0.005% BID
Participants applied E6201 0.005% cream to a pre-identified marker lesion twice a day (BID) for 8 weeks.
Participants applied matching placebo cream to another pre-identified marker lesion at the same treatment regimen.
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Experimental: E6201 0.01% BID
Participants applied E6201 0.01% cream to a pre-identified marker lesion BID for 8 weeks.
Participants applied matching placebo cream to another pre-identified marker lesion at the same treatment regimen.
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Experimental: E6201 0.03% BID
Participants applied E6201 0.03% cream to a pre-identified marker lesion BID for 8 weeks.
Participants applied matching placebo cream to another pre-identified marker lesion at the same treatment regimen.
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Experimental: E6201 0.03% QD
Participants applied E6201 0.03% cream to a pre-identified marker lesion once a day (QD) for 8 weeks.
Participants applied matching placebo cream to another pre-identified marker lesion at the same treatment regimen.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Total Symptom Severity (TSS) at week 8.
Time Frame: 8 weeks
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Total Symptom Severity (TSS) at all other time points; Physician's Global Assessment (PGA); safety; pharmacokinetics (PK)
Time Frame: Up to 12 weeks
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Up to 12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Eisai US Medical Services, Eisai Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
June 1, 2008
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
October 3, 2007
First Submitted That Met QC Criteria
October 3, 2007
First Posted (Estimate)
October 5, 2007
Study Record Updates
Last Update Posted (Estimate)
February 6, 2017
Last Update Submitted That Met QC Criteria
February 3, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E6201-A001-201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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