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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Limited )
ClinicalTrials.gov Identifier:
NCT01268527
First received: November 15, 2010
Last updated: June 26, 2014
Last verified: December 2012
  Purpose

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


Condition Intervention Phase
Psoriasis Vulgaris
Drug: E6201
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Demonstrate that at least one concentration of topical E6201 gel has superior efficacy compared with vehicle on the reduction of psoriatic infiltrate thickness during 12 days of treatment in subjects with psoriasis vulgaris [ Time Frame: 12 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the safety and tolerability of six topical concentrations of E6201 gel as measured by rates of adverse events, and relative to vehicle. [ Time Frame: 12 days of treatment plus the 7 day follow-up period ] [ Designated as safety issue: Yes ]
  • Explore the concentration/response relationship. [ Time Frame: 12 days of treatment ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: March 2010
Study Completion Date: February 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1 Drug: E6201
E6201 0.03% gel, topical once daily; E6201 0.1% gel, topical once daily; E6201 0.2% gel, topical once daily; gel vehicle, topical daily; calcipotriene (0.005%) topical, once daily.
Experimental: Cohort 2 Drug: E6201
E6201 .005% gel, topical once daily; E6201 0.01% gel, topical once daily; E6201 0.05% gel, topical once daily; gel vehicle, topical daily; calcipotriene(0.005%) topical, once daily.

Detailed Description:

This is a single center, randomized, blinded, intra-individual comparison in two sequential cohorts of 15 subjects each (30 subjects in total) in an outpatient setting, in which each subject simultaneously receives five topical treatments (3 active, 1 vehicle, and 1 positive control) within one or two psoriatic plaques. Treatments will consist of 3 concentrations of E6201 gel, a negative control (gel vehicle), and a positive control (0.005% calcipotriene cream).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01268527

Locations
Germany
Bioskin GmbH
Berlin, Germany
Sponsors and Collaborators
Eisai Limited
Investigators
Study Director: Joseph Mercer Eisai Limited
  More Information

No publications provided

Responsible Party: Eisai Inc. ( Eisai Limited )
ClinicalTrials.gov Identifier: NCT01268527     History of Changes
Other Study ID Numbers: E6201-E044-204, 2009-014815-11
Study First Received: November 15, 2010
Last Updated: June 26, 2014
Health Authority: United States: Food and Drug Administration
Germany: Federal Institaute for Drugs and Medical Devices

Keywords provided by Eisai Inc.:
Psoriasis vulgaris

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on October 22, 2014