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Paired-Comparison Study Evaluating the Efficacy and Safety of E6201 Versus Vehicle for the Treatment of Plaque-Type Psoriasis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Paired-Comparison Study Evaluating the Efficacy and Safety of E6201 Versus Vehicle for the Treatment of Plaque-Type Psoriasis

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

NCT00539929•Eisai Inc.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (12)

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

Key Dates

Start Date

September 1, 2007

Primary Completion Date

June 1, 2008

Completion Date

July 1, 2008

Last Updated

February 6, 2017

Enrollment

100

ACTUAL participants

Conditions

Chronic Plaque Psoriasis

Interventions

E6201 0.005%

DRUG

E6201 0.01%

DRUG

E6201 0.03%

DRUG

Placebo

DRUG

A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Placebo and an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

NCT03370133

Chronic Plaque PsoriasisModerate to Severe Chronic Plaque Psoriasis+1 more

View study

COMPLETEDPHASE3

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

NCT03598790

Chronic Plaque PsoriasisModerate to Severe Chronic Plaque Psoriasis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 6, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Paired-Comparison Study Evaluating the Efficacy and Safety of E6201 Versus Vehicle for the Treatment of Plaque-Type Psoriasis

Inclusion Criteria

Exclusion Criteria

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