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

Tracking Information

First Received Date ^ICMJE

October 3, 2007

Last Updated Date

August 26, 2009

Start Date ^ICMJE

September 2007

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Total Symptom Severity (TSS) at week 8. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Total Symptom Severity (TSS) at week 8.

Change History

Complete list of historical versions of study NCT00539929 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Total Symptom Severity (TSS) at all other time points; Physician's Global Assessment (PGA); safety; pharmacokinetics (PK)

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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. PK samples will be obtained pre-and post treatment.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Chronic Plaque Psoriasis

Intervention ^ICMJE

Drug: E6201

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

July 2009

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00539929

Responsible Party

Ger Rikken, M.D., Study Director, Eisai Medical Research Inc.

Study ID Numbers ^ICMJE

E6201-A001-201

Study Sponsor ^ICMJE

Eisai Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Michael Kuligowski, MD

Eisai Inc.

Information Provided By

Eisai Inc.

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP