Paired-Comparison Study Evaluating the Efficacy and Safety of E6201 Versus Vehicle for the Treatment of Plaque-Type Psoriasis
Completed · Phase 2 · Has a placebo group
Conditions studied: Chronic Plaque Psoriasis
In brief
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.
Key facts
- Study ID
- NCT00539929
- Run by
- Eisai Inc.
- People needed
- 100
- Starts
- 2007-09-01
- Expected to finish
- 2008-07-01
- Last updated by the study team
- 2017-02-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Study site — Hot Springs, Arkansas, United States
- Study site — San Diego, California, United States
- Study site — Boise, Idaho, United States
- Study site — Champaign, Illinois, United States
- Study site — Clinton Township, Michigan, United States
- Study site — Fridley, Minnesota, United States
- Study site — Omaha, Nebraska, United States
- Study site — Carlstadt, New Jersey, United States
- Study site — Portland, Oregon, United States
- Study site — Austin, Texas, United States
- Study site — College Station, Texas, United States
- Study site — Lynchburg, Virginia, United States
Full record on ClinicalTrials.gov
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