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: November 4, 2013
Last verified: November 2013
  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. PK samples will be obtained pre-and post treatment.


Condition Intervention Phase
Chronic Plaque Psoriasis
Drug: E6201
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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
Placebo Comparator: 1 Drug: E6201
Cream, twice daily.
Placebo Comparator: 2 Drug: E6201
Cream, twice daily.
Placebo Comparator: 3 Drug: E6201
Cream, twice daily.
Placebo Comparator: 4 Drug: E6201
Cream, once daily.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

  • Males or Females, ≥18 years of age.
  • Mild to moderate plaque-type psoriasis > 1 year.
  • Two representative marker lesions of similar size (15 to 25 cm^2 to 50 cm^2) must be present.

EXCLUSION CRITERIA

  • Use of any, concomitant treatment (topical and systemic) for psoriasis, excluding emollients. Psoriasis medications will require a wash-out prior to study entry.
  • Evidence of any clinically significant deviation from normal with regard to medical history, 12-lead ECG or laboratory determinations.
  • Presence of skin disease other than plaque type psoriasis.
  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

No publications provided

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: November 4, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 01, 2014