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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01052467
Other study ID # Treatment with Xamiol® Gel
Secondary ID
Status Completed
Phase N/A
First received January 19, 2010
Last updated February 18, 2014
Start date January 2010
Est. completion date May 2010

Study information

Verified date September 2010
Source LEO Pharma
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 724
Est. completion date May 2010
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Germany University Clinical Schleswig-Holstein, Campus Kiel Kiel

Sponsors (1)

Lead Sponsor Collaborator
LEO Pharma

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physician's Global Assessment of scalp psoriasis After approximately 4 weeks No
Secondary Patient's Quality of Life After approximately 4 weeks No
See also
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