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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT01052467
First received: January 19, 2010
Last updated: February 18, 2014
Last verified: September 2010
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient's Quality of Life [ Time Frame: After approximately 4 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01052467     History of Changes
Other Study ID Numbers: Treatment with Xamiol® Gel
Study First Received: January 19, 2010
Last Updated: February 18, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcipotriene
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014