NCT01052467

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
724

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 20, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

February 24, 2025

Status Verified

September 1, 2010

Enrollment Period

4 months

First QC Date

January 19, 2010

Last Update Submit

February 21, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Physician's Global Assessment of scalp psoriasis

    After approximately 4 weeks

Secondary Outcomes (1)

  • Patient's Quality of Life

    After approximately 4 weeks

Interventions

Once daily application for about 4 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients visiting their attending dermatologist in the primary care clinic

You may qualify if:

  • Patients with scalp psoriasis if a treatment with Xamiol® gel is planned anyway

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinical Schleswig-Holstein, Campus Kiel

Kiel, 24105, Germany

Location

Study Officials

  • Ulrich Mrowietz, MD

    University Clinic Schleswig-Holstein

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2010

First Posted

January 20, 2010

Study Start

January 1, 2010

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

February 24, 2025

Record last verified: 2010-09

Data Sharing

IPD Sharing
Will not share

Locations