CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 782 enrolled
Drug / intervention
Calcipotriol plus hydrocortisone ointment vehicle +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00640822
NCT00640822Phase 3Completed

A Phase 3 Study Comparing an Ointment Containing Calcipotriol 25 mcg/g Plus Hydrocortisone 10 mg g With Tacalcitol 4 mcg/g Ointment and the Ointment Vehicle Alone, All Applied Once Daily in the Treatment of Psoriasis Vulgaris on the Face and on the Intertriginous Areas

LEO Pharma·interventional·Posted Mar 21, 2008·Updated Mar 7, 2025

In Brief

A Phase 3 clinical trial evaluating Calcipotriol plus hydrocortisone ointment vehicle, Tacalcitol Ointment, and 1 other intervention for Psoriasis Vulgaris. Completed, enrolled 782 participants across 3 sites in 3 countries.

Detailed Summary

There are few therapies suitable for the treatment of psoriasis on the face and skin folds. As these areas are sensitive, irritation and other adverse reactions are more common than elsewhere on the body. The purpose of the study is to compare the efficacy and safety of once daily treatment for up to 8 weeks of an ointment containing calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g with tacalcitol 4 mcg/g ointment and the ointment vehicle alone in patients with psoriasis vulgaris on the face and on the intertriginous ares

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, France, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 21, 2008
Enrollment StartFeb 1, 2008
Primary CompletionJun 1, 2009
Study CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.3 years ago

Interventions

Calcipotriol plus hydrocortisone ointment vehicledrug

Once daily application for up to 8 weeks

Tacalcitol Ointmentdrug

Once daily application for up to 8 weeks

Calcipotriol plus hydrocortisone ointmentdrug

Once daily application for up to 8 weeks