Paired-Comparison Study Evaluating the Efficacy and Safety of E6201 Versus Vehicle for the Treatment of Plaque-Type Psoriasis
NCT ID: NCT00539929
Last Updated: 2017-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
100 participants
INTERVENTIONAL
2007-09-30
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
E6201 0.005%
Placebo
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.
E6201 0.01%
Placebo
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.
E6201 0.03%
Placebo
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.
E6201 0.03%
Placebo
Interventions
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E6201 0.005%
E6201 0.01%
E6201 0.03%
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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, 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.
18 Years
ALL
No
Sponsors
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Eisai Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Eisai US Medical Services
Role: STUDY_DIRECTOR
Eisai Inc.
Locations
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Hot Springs, Arkansas, United States
San Diego, California, United States
Boise, Idaho, United States
Champaign, Illinois, United States
Clinton Township, Michigan, United States
Fridley, Minnesota, United States
Omaha, Nebraska, United States
Carlstadt, New Jersey, United States
Portland, Oregon, United States
Austin, Texas, United States
College Station, Texas, United States
Lynchburg, Virginia, United States
Countries
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Other Identifiers
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E6201-A001-201
Identifier Type: -
Identifier Source: org_study_id
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