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Topical Treatment of Scalp Psoriasis With the Fixed Combination of Calcipotriol and Betamethason (Xamiol® Gel)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01052467
First Posted: January 20, 2010
Last Update Posted: February 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
LEO Pharma
  Purpose
This non-interventional, prospective, non-controlled study of Xamiol® Gel, a fixed combination of calcipotriol and betamethason dipropionate, shall investigate in daily routine the efficacy, tolerability and changes in quality-of-life parameters in patients with scalp psoriasis

Condition Intervention
Scalp Psoriasis Drug: Xamiol® Gel

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Topical Treatment of Scalp Psoriasis With the Fixed Combination of Calcipotriol and Betamethason (Xamiol® Gel)

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • Physician's Global Assessment of scalp psoriasis [ Time Frame: After approximately 4 weeks ]

Secondary Outcome Measures:
  • Patient's Quality of Life [ Time Frame: After approximately 4 weeks ]

Enrollment: 724
Study Start Date: January 2010
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Xamiol® Gel
    Once daily application for about 4 weeks
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients visiting their attending dermatologist in the primary care clinic
Criteria

Inclusion Criteria:

  • Patients with scalp psoriasis if a treatment with Xamiol® gel is planned anyway

Exclusion Criteria:

  • Contraindications of Xamiol® Gel listed in the German package insert
  • Pretreatment with Xamiol® within the last 4 weeks
  • Systemic treatment of psoriasis
  • UV light therapy
  Contacts and Locations
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): NCT01052467


Locations
Germany
University Clinical Schleswig-Holstein, Campus Kiel
Kiel, Germany, 24105
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Ulrich Mrowietz, MD University Clinic Schleswig-Holstein
  More Information

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01052467     History of Changes
Other Study ID Numbers: Treatment with Xamiol® Gel
First Submitted: January 19, 2010
First Posted: January 20, 2010
Last Update Posted: February 19, 2014
Last Verified: September 2010

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcipotriene
Dermatologic Agents