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

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:

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

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 ]

Estimated 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

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 US Medical Services, Eisai Medical Research Inc.
ClinicalTrials.gov Identifier:	NCT00539929 History of Changes
Other Study ID Numbers:	E6201-A001-201
Study First Received:	October 3, 2007
Last Updated:	March 31, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013