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Trial record 40 of 272 for:    Betamethasone

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

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ClinicalTrials.gov Identifier: NCT00216892
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : March 26, 2015
Sponsor:
Information provided by:
LEO Pharma

Brief 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


Condition or disease Intervention/treatment Phase
Psoriasis Vulgaris Drug: Calcipotriol, (calcipotriol + betamethasone) Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 1032 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Different Treatment Regimens of Calcipotriol Cream and Combination (Calcipotriol/Betamethasone Dipropionate) Ointment in Psoriasis Vulgaris
Study Start Date : April 2005
Study Completion Date : December 2005





Primary Outcome Measures :
  1. Efficacy of regimen (a) versus regimen (c) by % change in PASI at week 12

Secondary Outcome Measures :
  1. Efficacy of regimen (b) versus regimen (c) at week 12, safety of regimen (a) versus (c), safety of regimen (b) versus (c)


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with psoriasis vulgaris of trunk and/or limbs

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00216892


Locations
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Belgium
Universitair Ziekenhuis
Gent, Belgium, 9000
Canada, Ontario
Dermatrials Research Dermatology Centre
Hamilton, Ontario, Canada, L8N 1V6
France
Hôpital Nord, Service de Dermatologie
Saint Etienne, France, 42055
Germany
Klinikum der Goethe-Universität, Zentrum für Dermatologie und Venerologie
Frankfurt, Germany, 60590
Netherlands
Canisius-Wilhelmina Ziekenhuis
Nijmegen, Netherlands, 6532
Spain
Hospital Mutua de Terrassa Dermatology Service
Terrassa, Spain, 08221
United Kingdom
Clatterbridge Hospital, Department of Dermatology
Merseyside, United Kingdom, L63 4JY
Sponsors and Collaborators
LEO Pharma
Investigators
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Principal Investigator: S White, MD Clatterbridge Hospital, Department of Dermatology

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ClinicalTrials.gov Identifier: NCT00216892     History of Changes
Other Study ID Numbers: MCB 0402 INT
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Betamethasone sodium phosphate
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcitriol
Calcipotriene
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Calcium-Regulating Hormones and Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents