Clinical trial NCT01268527
Conditions: Psoriasis Vulgaris
Keywords: Psoriasis vulgaris
Sponsor: Eisai Limited
Start date: 2010-03-15; Completion date: 2010-12-11
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: Three concentrations of E6201 topical gel (0.03%, 0.1%, and 0.2%) and active comparator, calcipotriene cream (0.005%), were applied once daily for 12 days to specific test fields determined at Baseline. The 3 concentrations of E6201 gel were dosed first in Cohort 1 to establish the safety and tolerability prior to dosing in Cohort 2. arm 2: Three concentrations of E6201 topical gel (0.005%, 0.01%, and 0.05%) and active comparator, calcipotriene cream (0.005%), were applied once daily for 12 days to specific test fields determined at Baseline. Cohort 2 participants were not dosed until all participants in Cohort 1 completed treatment and safety data were collected and evaluated.
Interventions: intervention 1: 0.03% E6201 intervention 2: 0.1% E6201 intervention 3: 0.2% E6201 intervention 4: 0.005% E6201 intervention 5: 0.01% E6201 intervention 6: 0.05% E6201 intervention 7: Placebo - 0.03% gel vehicle intervention 8: Placebo - 0.1% gel vehicle intervention 9: Placebo - 0.2% gel vehicle intervention 10: Placebo - 0.05% gel vehicle intervention 11: Placebo - 0.01% gel vehicle intervention 12: Placebo - 0.05% gel vehicle intervention 13: Calcipotriene
Intervention descriptions: intervention 1: Topical 0.03% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque. intervention 2: Topical 0.1% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque. intervention 3: Topical 0.2% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque. intervention 4: Topical 0.005% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque. intervention 5: Topical 0.01% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque. intervention 6: Topical 0.05% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque. intervention 7: Topical 0.03% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque. intervention 8: Topical 0.1% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque. intervention 9: Topical 0.2% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque. intervention 10: Topical 0.005% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque. intervention 11: Topical 0.01% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque. intervention 12: Topical 0.05% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque. intervention 13: Topical 0.005% calcipotriene (positive control) was applied once daily to individual specific regions of the psoriatic plaque.

Protocol documents: