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
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Intervention: 0.03% E6201; 0.1% E6201; 0.2% E6201; 0.005% E6201; 0.01% E6201; 0.05% E6201; Placebo - 0.03% gel vehicle; Placebo - 0.1% gel vehicle; Placebo - 0.2% gel vehicle; Placebo - 0.05% gel vehicle; Placebo - 0.01% gel vehicle; Placebo - 0.05% gel vehicle; Calcipotriene
Intervention description: Topical 0.03% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque.; Topical 0.1% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque.; Topical 0.2% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque.; Topical 0.005% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque.; Topical 0.01% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque.; Topical 0.05% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque.; Topical 0.03% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque.; Topical 0.1% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque.; Topical 0.2% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque.; Topical 0.005% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque.; Topical 0.01% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque.; Topical 0.05% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque.; Topical 0.005% calcipotriene (positive control) was applied once daily to individual specific regions of the psoriatic plaque.
Intervention MeSH terms: Calcipotriene
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: 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.
    

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