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Efficacy and Safety of Calcipotriol Cream and (Calcipotriol + Betamethasone Dipropionate) Ointment in Psoriasis Vulgaris

Primary Purpose

Psoriasis Vulgaris

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Calcipotriol, (calcipotriol + betamethasone)

About this trial

This is an interventional treatment trial for Psoriasis Vulgaris

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with psoriasis vulgaris of trunk and/or limbs Exclusion Criteria: -

Sites / Locations

Universitair Ziekenhuis
Dermatrials Research Dermatology Centre
Hôpital Nord, Service de Dermatologie
Klinikum der Goethe-Universität, Zentrum für Dermatologie und Venerologie
Canisius-Wilhelmina Ziekenhuis
Hospital Mutua de Terrassa Dermatology Service
Clatterbridge Hospital, Department of Dermatology

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00216892

First Posted

September 15, 2005

Last Updated

March 25, 2015

Sponsor

LEO Pharma

1. Study Identification

Unique Protocol Identification Number

NCT00216892

Brief Title

Efficacy and Safety of Calcipotriol Cream and (Calcipotriol + Betamethasone Dipropionate) Ointment in Psoriasis Vulgaris

Official Title

Different Treatment Regimens of Calcipotriol Cream and Combination (Calcipotriol/Betamethasone Dipropionate) Ointment in Psoriasis Vulgaris

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

April 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

LEO Pharma

4. Oversight

5. Study Description

Brief Summary

Patients with psoriasis vulgaris of the trunk and/or limbs are randomised to treatment with: 4 weeks of ointment containing calcipotriol and betamethasone dipropionate followed by 8 weeks of calcipotriol cream 4 weeks of (calcipotriol plus betamethasone dipropionate) ointment followed by 8 weeks of calcipotriol cream on weekdays/ (calcipotriol plus betamethasone dipropionate) ointment on weekends 4 weeks of (calcipotriol plus betamethasone dipropionate) ointment followed by 8 weeks of vehicle of calcipotriol cream The objective is to compare the efficacy and safety of the different treatment regimens

Detailed Description

A phase IV study of different treatment regimens of calcipotriol 50 mcg/g cream and combination (calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)) ointment following treatment with combination ointment in psoriasis vulgaris

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis Vulgaris

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

1032 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Calcipotriol, (calcipotriol + betamethasone)

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with psoriasis vulgaris of trunk and/or limbs Exclusion Criteria: -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

S White, MD

Organizational Affiliation

Clatterbridge Hospital, Department of Dermatology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Universitair Ziekenhuis

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Dermatrials Research Dermatology Centre

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 1V6

Country

Canada

Facility Name

Hôpital Nord, Service de Dermatologie

City

Saint Etienne

ZIP/Postal Code

42055

Country

France

Facility Name

Klinikum der Goethe-Universität, Zentrum für Dermatologie und Venerologie

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Facility Name

Canisius-Wilhelmina Ziekenhuis

City

Nijmegen

ZIP/Postal Code

6532

Country

Netherlands

Facility Name

Hospital Mutua de Terrassa Dermatology Service

City

Terrassa

ZIP/Postal Code

08221

Country

Spain

Facility Name

Clatterbridge Hospital, Department of Dermatology

City

Merseyside

ZIP/Postal Code

L63 4JY

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of Calcipotriol Cream and (Calcipotriol + Betamethasone Dipropionate) Ointment in Psoriasis Vulgaris

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