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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 18, 2014