NCT00216892

Brief Summary

Patients with psoriasis vulgaris of the trunk and/or limbs are randomised to treatment with:

  1. 1.4 weeks of ointment containing calcipotriol and betamethasone dipropionate followed by 8 weeks of calcipotriol cream
  2. 2.4 weeks of (calcipotriol plus betamethasone dipropionate) ointment followed by 8 weeks of calcipotriol cream on weekdays/ (calcipotriol plus betamethasone dipropionate) ointment on weekends
  3. 3.4 weeks of (calcipotriol plus betamethasone dipropionate) ointment followed by 8 weeks of vehicle of calcipotriol cream

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,032

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2005

Shorter than P25 for phase_4

Geographic Reach
7 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

February 24, 2025

Status Verified

March 1, 2015

First QC Date

September 15, 2005

Last Update Submit

February 21, 2025

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

  • Efficacy of regimen (a) versus regimen (c) by % change in PASI at week 12

Secondary Outcomes (1)

  • Efficacy of regimen (b) versus regimen (c) at week 12, safety of regimen (a) versus (c), safety of regimen (b) versus (c)

Interventions

Calcipotriol, (calcipotriol + betamethasone)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with psoriasis vulgaris of trunk and/or limbs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Universitair Ziekenhuis

Ghent, 9000, Belgium

Location

Dermatrials Research Dermatology Centre

Hamilton, Ontario, L8N 1V6, Canada

Location

Hôpital Nord, Service de Dermatologie

Saint-Etienne, 42055, France

Location

Klinikum der Goethe-Universität, Zentrum für Dermatologie und Venerologie

Frankfurt, 60590, Germany

Location

Canisius-Wilhelmina Ziekenhuis

Nijmegen, 6532, Netherlands

Location

Hospital Mutua de Terrassa Dermatology Service

Terrassa, 08221, Spain

Location

Clatterbridge Hospital, Department of Dermatology

Merseyside, L63 4JY, United Kingdom

Location

Related Links

MeSH Terms

Interventions

calcipotrieneBetamethasone

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • S White, MD

    Clatterbridge Hospital, Department of Dermatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 22, 2005

Study Start

April 1, 2005

Study Completion

December 1, 2005

Last Updated

February 24, 2025

Record last verified: 2015-03

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)GB(1)FR(1)BE(1)ES(1)CA(1)DE(1)