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

• Status: Completed
• Trial end date: 2010-12-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eisai Limited
• Treatments: Calcipotriene

Criteria

Inclusion:

• Chronic stable plaque psoriasis with one or two stable psoriatic plaques(s) suitable in size and location for five separate treatment fields to be assessed within it.

• Males and females aged between 18 and 75 years of age

• The general physical examination should be normal (excluding the skin examination for psoriasis) unless the Investigator considers an abnormality not to be clinically significant with regard to the study

• Females of childbearing potential must have a negative serum beta-human chorionic gonadotropin at Visit 1 (Screening) and a negative urine pregnancy test prior to starting study drug(s) (Visit 2). Female subjects of childbearing potential must agree to be abstinent or to use a highly effective method of contraception throughout the study period and for 30 days after the last dose of study drug.

• Provide written informed consent

• Willing and able to comply with all aspects of the protocol

Exclusion:

• Any clinically significant skin diseases other then chronic stable plaque psoriasis

• Other types of psoriasis than chronic stable plaque variant eg, guttate, pustular, erythodermic, etc

• An unstable course of the disease defined as flare(s) in the previous month

• Subjects who used any concommitant topical treatment for the psoriatic plaque(s) to be studied (other than emollients or salicylic acid) within 8 weeks before the Baseline visit eg corticosteroids or topical immunomodulators, anthralin (dithranil), vitamin D derivatives, ultraviolet-light therapy including sunbathing , or retinoids.

• Subjects who used any of the following systemic treatments within 12 weeks before the Baseline visit eg: corticosteroids or adrenocorticotrophic hormone analogs, retinoids such as acitretin or isotretinoin, cyclosporin, interferon, methotrexate, other immuno-suppressive/immunomodulating drugs, psoralen and ultraviolet A therapy, or biologics

• Subjects planning on significant exposure to sun (sun-bathing)

• Treatment with systemic or locally acting medications which might counter or influence the study aim (eg monoamine oxidase inhibitors, anti-epileptic drugs, anti-psychotic drugs) or medications which are known to provoke or aggravate psoriasis, eg Beta-blockers, antimalarial drugs, and lithium within two weeks before the Baseline visit

• Subject is a dependent person, ie, a relative/family member of the Investigator and/or is a member of the Investigator's staff

• Clinical study participation with any investigational drug less than 30 days prior to study entry or planning to receive an investigational drug during the study period