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

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.

Timeline

Start

2010-03-15

Primary completion

2010-12-11

Completion

2010-12-11

Outcome

Mixed primary results

registry analysis (superiority test); E6201 Vehicle vs 0.005% E6201 Gel; p = 0.0038; Difference in LSM (vehicle - E6201 gel) 711.4 (95% CI 292.5 to 1130.3) NCT01268527 ↗

registry analysis (superiority test); E6201 Vehicle vs 0.03% E6201 Gel; p = 0.0523; Difference in LSM (vehicle - E6201 gel) 780.0 (95% CI -8.5 to 1568.5) NCT01268527 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Calcipotriene	Other / unclassified	0.005 %	Topical
Subject	E6201	Small molecule	0.005 %	Topical
Subject	E6201	Small molecule	0.01 %	Topical
Subject	E6201	Small molecule	0.03 %	Topical
Subject	E6201	Small molecule	0.05 %	Topical
Subject	E6201	Small molecule	0.1 %	Topical
Subject	E6201	Small molecule	0.2 %	Topical

Indications