ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT01052467
Recruitment Status : Completed
First Posted : January 20, 2010
Last Update Posted : February 19, 2014
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Brief Summary:
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 or disease Intervention/treatment
Scalp Psoriasis Drug: Xamiol® Gel

Study Type : Observational
Actual Enrollment : 724 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Topical Treatment of Scalp Psoriasis With the Fixed Combination of Calcipotriol and Betamethason (Xamiol® Gel)
Study Start Date : January 2010
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis


Intervention Details:
  • Drug: Xamiol® Gel
    Once daily application for about 4 weeks


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

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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

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

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