A 12-Day Randomized, Blinded, Vehicle and Active Comparator-Controlled Study to Determine the Efficacy and Safety of Six Concentrations of Topical E6201 Gel in Subjects With Psoriasis Vulgaris

Summary

The purpose of this study is to investigate the efficacy, safety, tolerability and the concentration/response relationship of E6201 in subjects with psoriasis vulgaris.

Conditions

• Psoriasis Vulgaris

Interventions

DRUG

0.03% E6201

Topical 0.03% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque.

DRUG

0.1% E6201

Topical 0.1% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque.

DRUG

0.2% E6201

Topical 0.2% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque.

DRUG

0.005% E6201

Topical 0.005% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque.

DRUG

0.01% E6201

Topical 0.01% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque.

DRUG

0.05% E6201

Topical 0.05% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque.

OTHER

Placebo - 0.03% gel vehicle

Topical 0.03% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque.

OTHER

Placebo - 0.1% gel vehicle

Topical 0.1% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque.

OTHER

Placebo - 0.2% gel vehicle

Topical 0.2% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque.

OTHER

Placebo - 0.05% gel vehicle

Topical 0.005% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque.

OTHER

Placebo - 0.01% gel vehicle

Topical 0.01% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque.

OTHER

Placebo - 0.05% gel vehicle

Topical 0.05% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque.

DRUG

Calcipotriene

Topical 0.005% calcipotriene (positive control) was applied once daily to individual specific regions of the psoriatic plaque.

Sponsors & Collaborators

• Eisai Limited

  lead INDUSTRY

Principal Investigators

• Joseph Mercer · Eisai Limited

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-03-15

Primary Completion

2010-12-11

Completion

2010-12-11

Countries

• Germany

Study Locations