NCT01466478

An Exploratory Psoriasis Plaque Test Study With LEO 29102 Plus Calcipotriol, Ointment, in Psoriasis Vulgaris

A Phase I Exploratory Study Evaluating 3 Formulations of LEO 29102 Plus Calcipotriol, Ointment, LEO 29102 Ointment, Calcipotriol Ointment, Daivonex® Ointment and Diprosone® Ointment in the Treatment of Psoriasis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to compare the 3 ointment formulations containing LEO 29102 plus calcipotriol and Daivonex® ointment and Diprosone® ointment and to compare LEO 29102 plus calcipotriol to LEO 29102 alone and to calcipotriol alone in the same ointment vehicle, using the psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.

Conditions

• Psoriasis Vulgaris

Interventions

Type	Name	Description
DRUG	Ointment A: LEO 29102 2.5 mg/g plus calcipotriol 50 µg/g ointment	once daily application, 4 weeks
DRUG	Ointment B: LEO 29102 2.5 mg/g ointment	once daily application, 4 weeks
DRUG	Ointment C: Calcipotriol 50 µg/g ointment	once daily application, 4 weeks
DRUG	Ointment D: LEO 29102 2.5 mg/g plus calcipotriol 50 µg/g ointment	once daily application, 4 weeks
DRUG	Ointment G: LEO 29102 2.5 mg/g plus calcipotriol 50 µg/g ointment	once daily application, 4 weeks
DRUG	Daivonex® ointment	once daily application, 4 weeks
DRUG	Diprosone® ointment	once daily application, 4 weeks

Timeline

• Start date: 2011-11-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2011-11-08
• Last updated: 2025-02-24

Locations

1 site across 1 country: France