Efficacy of Calcipotriol Plus Betamethasone Gel Versus Calcipotriol Scalp Solution in Scalp Psoriasis

March 25, 2015 updated by: LEO Pharma

Calcipotriol Plus Betamethasone Dipropionate Gel Compared to DAIVONEX/DOVONEX Scalp Solution in Patients With Scalp Psoriasis

The purpose of this study is to evaluate whether once daily treatment for up to 8 weeks of calcipotriol plus betamethasone dipropionate gel is more effective than twice daily treatment of calcipotriol scalp solution in patients with scalp psoriasis. The primary outcome is patients with clear or minimal disease after 8 weeks treatment.

Further the occurrence of relapse and rebound after end of treatment in patients with clear or minimal disease will be investigated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Universitair Ziekenhuis Sint Raphaël, Dienst Dermatologie
  • Canada
    • Ontario
      • Windsor, Ontario, Canada, N8W5L7
        • Windsor Clinical Research Inc.
  • Denmark
      • Aarhus, Denmark, 8000
        • Department of Dermatology, Marselisborg Centres
  • France
      • Nice, France, 06202
        • Hôpital de L'Archet, Service de Dermatologie
  • Sweden
      • Göteborg, Sweden, 41135
        • Läkarhuset

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Main Inclusion Criteria:

  • Scalp psoriasis amenable to topical treatment
  • Psoriasis vulgaris on trunk and/or limbs
  • Extent of scalp psoriasis involving more than 10% of the total scalp area
  • Disease severity on the scalp graded as moderate or worse by the investigator
  • Consenting out-patients of 18 years or above

Main Exclusion Criteria:

  • PUVA or Grenz ray therapy within 4 weeks prior to randomisation
  • UVB therapy within 2 weeks prior to randomisation
  • Systemic treatment with biological therapies, with a possible effect on scalp psoriasis within 6 months prior to randomisation
  • Systemic treatment with all other therapies than biologicals, with a possible effect on scalp psoriasis (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within 4 weeks prior to randomisation
  • Any topical treatment of the scalp (except for non steroid medicated shampoos and emollients) within 2 weeks prior to randomisation
  • Topical treatment of the face, trunk and/or limbs with very potent WHO group IV corticosteroids within 2 weeks prior to randomisation
  • Current diagnosis of erythrodermic, exfoliative or pustular psoriasis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall disease severity according to investigator's assessment at week 8

Secondary Outcome Measures

Outcome Measure
Total sign score at week 8
Overall disease severity according to patients at week 8
Score for redness, thickness and scaliness at week 8
Overall disease severity according to the investigator's assessment at week 2 and 4
Relapse and rebound during the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LEO Pharma

Investigators

  • Principal Investigator: Knud Kragballe, MD, Department of Dermatology, Marselisborg Centres

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion

May 1, 2006

Study Registration Dates

First Submitted

October 21, 2005

First Submitted That Met QC Criteria

October 21, 2005

First Posted (Estimate)

October 24, 2005

Study Record Updates

Last Update Posted (Estimate)

March 26, 2015

Last Update Submitted That Met QC Criteria

March 25, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MBL 0503 INT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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