- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01052467
Topical Treatment of Scalp Psoriasis With the Fixed Combination of Calcipotriol and Betamethason (Xamiol® Gel)
February 21, 2025 updated by: LEO Pharma
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
Study Overview
Study Type
Observational
Enrollment (Actual)
724
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
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Kiel, Germany, 24105
- University Clinical Schleswig-Holstein, Campus Kiel
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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
Sampling Method
Non-Probability Sample
Study Population
Patients visiting their attending dermatologist in the primary care clinic
Description
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
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Physician's Global Assessment of scalp psoriasis
Time Frame: After approximately 4 weeks
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After approximately 4 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Patient's Quality of Life
Time Frame: After approximately 4 weeks
|
After approximately 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ulrich Mrowietz, MD, University Clinic Schleswig-Holstein
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
January 1, 2010
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
January 19, 2010
First Submitted That Met QC Criteria
January 19, 2010
First Posted (Estimated)
January 20, 2010
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 21, 2025
Last Verified
September 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Treatment with Xamiol® Gel
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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