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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00539929
First received: October 3, 2007
Last updated: February 3, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention Phase
Chronic Plaque Psoriasis
Drug: E6201 0.005%
Drug: E6201 0.01%
Drug: E6201 0.03%
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Total Symptom Severity (TSS) at week 8. [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • Total Symptom Severity (TSS) at all other time points; Physician's Global Assessment (PGA); safety; pharmacokinetics (PK) [ Time Frame: Up to 12 weeks ]

Enrollment: 100
Study Start Date: September 2007
Study Completion Date: July 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: E6201 0.005% Drug: Placebo
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.
Drug: E6201 0.01% Drug: Placebo
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.
Drug: E6201 0.03% Drug: Placebo
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.
Drug: E6201 0.03% Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00539929

Locations
United States, Arkansas
Hot Springs, Arkansas, United States
United States, California
San Diego, California, United States
United States, Idaho
Boise, Idaho, United States
United States, Illinois
Champaign, Illinois, United States
United States, Michigan
Clinton Township, Michigan, United States
United States, Minnesota
Fridley, Minnesota, United States
United States, Nebraska
Omaha, Nebraska, United States
United States, New Jersey
Carlstadt, New Jersey, United States
United States, Oregon
Portland, Oregon, United States
United States, Texas
Austin, Texas, United States
College Station, Texas, United States
United States, Virginia
Lynchburg, Virginia, United States
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Eisai US Medical Services Eisai Inc.
  More Information

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00539929     History of Changes
Other Study ID Numbers: E6201-A001-201
Study First Received: October 3, 2007
Last Updated: February 3, 2017

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on May 25, 2017