Clinical Trials Logo
  1. Home
  2. Psoriasis Vulgaris
  3. NCT00216892
  4. Details
NCT00216892 Clinical Trial

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

Psoriasis Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00216892
Other study ID # MCB 0402 INT
Secondary ID
Status Completed
Phase Phase 4
First received September 15, 2005
Last updated March 25, 2015
Start date April 2005
Est. completion date December 2005

Study information
Verified date March 2015
Source LEO Pharma
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicines and Health Products, FAMHPCanada: Health CanadaFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesNetherlands: Dutch Health Care InspectorateSpain: Spanish Agency of MedicinesUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

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

1. 4 weeks of ointment containing calcipotriol and betamethasone dipropionate followed by 8 weeks of calcipotriol cream

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. 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

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

Recruitment information / eligibility
Status Completed
Enrollment 1032
Est. completion date December 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with psoriasis vulgaris of trunk and/or limbs

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Calcipotriol, (calcipotriol + betamethasone)

Locations
Country Name City State
Belgium Universitair Ziekenhuis Gent
Canada Dermatrials Research Dermatology Centre Hamilton Ontario
France Hôpital Nord, Service de Dermatologie Saint Etienne
Germany Klinikum der Goethe-Universität, Zentrum für Dermatologie und Venerologie Frankfurt
Netherlands Canisius-Wilhelmina Ziekenhuis Nijmegen
Spain Hospital Mutua de Terrassa Dermatology Service Terrassa
United Kingdom Clatterbridge Hospital, Department of Dermatology Merseyside

Sponsors (1)
Lead Sponsor Collaborator
LEO Pharma

Countries where clinical trial is conducted

Belgium,  Canada,  France,  Germany,  Netherlands,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy of regimen (a) versus regimen (c) by % change in PASI at week 12
Secondary Efficacy of regimen (b) versus regimen (c) at week 12, safety of regimen (a) versus (c), safety of regimen (b) versus (c)
See also
  Status Clinical Trial Phase
Completed NCT03669757 - Clinical Trial to Assess Safety, Tolerability and the Pharmacodynamic Effect of Different Concentrations of a New Anti-inflammatory Substance in Subjects With Chronic Plaque Psoriasis Phase 1
Completed NCT03614078 - A Study of PRCL-02 in Moderate to Severe Chronic Plaque Psoriasis Phase 2
Completed NCT03584360 - Role of Topical Treatments in the Modulation of Skin Microbiome in Psoriatic Skin Phase 2
Recruiting NCT04994951 - Pilot Study of Traditional Chinese Medicine (Qing-Re-Liang-Xue Decoction) as Complementary Medicine for Psoriasis Vulgaris of Blood-heat Syndrome. Phase 2
Completed NCT02888236 - LEO 32731 for the Treatment of Moderate to Severe Psoriasis Vulgaris Phase 2
Completed NCT02533973 - Long-term Treatment of Scalp Psoriasis With Xamiol® Gel in a Large Adult Chinese Population Phase 4
Completed NCT02193815 - A 12 Day Study To Evaluate A Topical Drug To Treat Plaque Psoriasis Phase 1
Completed NCT02004847 - Blue Light for Treating Psoriasis Vulgaris N/A
Completed NCT01946386 - A Vasoconstriction Study With LEO 90100 Phase 1
Recruiting NCT01443338 - Study Evaluating the Efficacy and Safety of Triptergium Wilfordii and Acitretin in Psoriasis Vulgaris - CHINA201002016-2 Phase 4
Completed NCT01188928 - LEO 80185 in the Treatment of Psoriasis Vulgaris on the Non-scalp Regions of the Body (Trunk and/or Limbs) Phase 3
Completed NCT00764751 - Efficacy and Safety of LEO 19123 Cream in the Treatment of Psoriasis Vulgaris Phase 2
Completed NCT00236171 - Evaluation of Topical Antipsoriatics in the Psoriasis Plaque Test N/A
Completed NCT04541329 - Predicting Inflammatory Skin Disease Response to IL-23 Blockade Phase 4
Completed NCT06064084 - Incretin Effect in Patients With Psoriasis and Controls
Not yet recruiting NCT06398106 - Proactive TDM Versus Standard Use of Biologics in Psoriasis Phase 4
Recruiting NCT05390515 - Psoriatic Immune Response to Tildrakizumab Phase 4
Recruiting NCT05892640 - Low-Salt Diet Effect on Th17-Mediated Inflammation and Vascular Reactivity in Psoriasis N/A
Recruiting NCT04950218 - The Psoriasis Echo Study
Completed NCT05184348 - Plexin B2 Gene Expression and Polymorphisms in Psoriasis Phase 1

External Links