Clinical trial NCT01268527: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis Vulgaris
Keywords: Psoriasis vulgaris
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2010-12-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 consisted of 3 concentrations of E6201 gel, a negative control (gel vehicle), and a positive control (0.005% calcipotriene cream). The different concentrations of E6201 gel and vehicle control were double-blinded, while the calciprotriene cream was single-blinded. Cohort 2 participants were not dosed until all participants in Cohort 1 completed treatment and safety data were collected and evaluated.

Eligibility 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

Primary outcomes:
measure: Summary Statistics and Primary Pairwise Comparison (Vehicle-E6201) of Area Under the Curve (AUC) for the Baseline-Corrected Thickness of the Psoriatic Infiltrate
timeFrame: Day 0 (Baseline), Day 8 (Visit 10), and Day 12 (End of Treatment)
Secondary outcomes:
measure: Change in Thickness of the Psoriatic Infiltrate From Baseline to End of Treatment (Day 12/Discontinuation)
timeFrame: Day 12/Discontinuation (Visit 14/End of Treatment)
measure: Change in Thickness of the Psoriatic Infiltrate From Baseline to Day 8
timeFrame: Day 8 (Visit 10)
measure: Clinical (Global) Assessment of Efficacy at Day 12/Discontinuation
timeFrame: Day 12/Discontinuation (Visit 14/End of Treatment)
measure: Clinical (Global) Assessment of Efficacy on Day 8
timeFrame: Day 8 (Visit 10)
measure: Overview of Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From first dose of study treatment up to 30 days after the last dose, or until resolution, whichever came first, or up to approximately 10 months.
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Bioskin GmbH
Study officials:
affiliation: Eisai Limited
name: Joseph Mercer
role: STUDY_DIRECTOR
References: