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
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): 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 type(s): Drug; Drug; Drug; Drug; Drug; Drug; Other; Other; Other; Other; Other; Other; Drug
Intervention description(s): 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.
Other intervention name(s): Daivonex
Intervention MeSH terms: Calcipotriene
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: Psoriasis vulgaris