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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Eisai Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Psoriasis Vulgaris

Interventions

Type	Name	Description
DRUG	0.03% E6201	Topical 0.03% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque.
DRUG	0.1% E6201	Topical 0.1% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque.
DRUG	0.2% E6201	Topical 0.2% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque.
DRUG	0.005% E6201	Topical 0.005% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque.
DRUG	0.01% E6201	Topical 0.01% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque.
DRUG	0.05% E6201	Topical 0.05% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque.
OTHER	Placebo - 0.03% gel vehicle	Topical 0.03% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque.
OTHER	Placebo - 0.1% gel vehicle	Topical 0.1% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque.
OTHER	Placebo - 0.2% gel vehicle	Topical 0.2% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque.
OTHER	Placebo - 0.05% gel vehicle	Topical 0.005% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque.
OTHER	Placebo - 0.01% gel vehicle	Topical 0.01% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque.
OTHER	Placebo - 0.05% gel vehicle	Topical 0.05% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque.
DRUG	Calcipotriene	Topical 0.005% calcipotriene (positive control) was applied once daily to individual specific regions of the psoriatic plaque.

Timeline

• Start date: 2010-03-15
• Primary completion: 2010-12-11
• Completion: 2010-12-11
• First posted: 2010-12-31
• Last updated: 2021-06-11
• Results posted: 2021-06-11

Locations

1 site across 1 country: Germany