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

Sponsored by:	Eisai Medical Research Inc.
Information provided by:	Eisai Medical Research Inc.
ClinicalTrials.gov Identifier:	NCT00539929

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 II

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Eisai Medical Research 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
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Drug: E6201 Cream, twice daily.
2: Placebo Comparator	Drug: E6201 Cream, twice daily.
3: Placebo Comparator	Drug: E6201 Cream, twice daily.
4: Placebo Comparator	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, Texas
Dr. Terry Jones, M.D.
Bryan, Texas, United States, 77802

Sponsors and Collaborators

Eisai Medical Research Inc.

Investigators

Study Director:

Michael Kuligowski, MD

Eisai Medical Research Inc.

More Information

Responsible Party:	Eisai Medical Research Inc. ( Ger Rikken, M.D., Study Director )
Study ID Numbers:	E6201-A001-201
Study First Received:	October 3, 2007
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00539929
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on January 16, 2009