NCT01607853

A Short-contact Plaque Test Study With Daivobet® Gel in Psoriasis Vulgaris

A Phase IIa Exploratory Study Evaluating the Anti-psoriatic Effect of Daivobet® Gel Applied Then Removed After 10 Minutes, Daivobet® Gel Applied Then Removed After 20 Minutes, Daivobet® Gel Applied for 24 Hours and Daivobet® Gel Vehicle Applied for 24 Hours

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the anti-psoriatic effect of Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes), Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) compared with Daivobet® gel and Daivobet® gel vehicle applied for 24 hours (+/- 2 hours), using the psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.

Conditions

• Psoriasis Vulgaris

Interventions

Type	Name	Description
DRUG	Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes)	Once daily application, 3 weeks
DRUG	Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes)	Once daily application, 3 weeks
DRUG	Daivobet® gel applied for 24 hours (+/- 2 hours)	Once daily application, 3 weeks
DRUG	Daivobet® gel vehicle applied for 24 hours (+/- 2 hours)	Once daily application, 3 weeks

Timeline

• Start date: 2012-06-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2012-05-30
• Last updated: 2025-03-10
• Results posted: 2013-12-24

Locations

1 site across 1 country: France