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

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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 is ongoing, but not recruiting participants.

Study NCT00539929. Last updated on July 23, 2008. Information provided by Eisai Medical Research Inc.

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

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

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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 ]

Condition ^†

Chronic Plaque Psoriasis

Intervention ^†

Drug: E6201

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

100

Start Date ^†

September 2007

Completion Date

October 2008

Eligibility 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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00539929

Organization ID

E6201-A001-201

Secondary IDs ^††

Study Sponsor ^†

Eisai Medical Research Inc.

Collaborators ^††

Investigators ^†

Study Director:

Michael Kuligowski, MD

Eisai Medical Research Inc.

Information Provided By

Eisai Medical Research Inc.

Verification Date

July 2008

First Received Date ^†

October 3, 2007

Last Updated Date

July 23, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.