Scalp PsoriasisNCT01052467
Topical Treatment of Scalp Psoriasis With the Fixed Combination of Calcipotriol and Betamethason (Xamiol® Gel)
An observational study of Scalp Psoriasis, run by LEO Pharma at 1 site in Germany.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scalp Psoriasis
- What is being tested?
- Xamiol® Gel
- How many people
- 724 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2010to May 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients visiting their attending dermatologist in the primary care clinic
Who may be able to join
- Patients with scalp psoriasis if a treatment with Xamiol® gel is planned anyway
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Scalp Psoriasis
- Being tested
- Xamiol® Gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xamiol® GelDrug
Once daily application for about 4 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician's Global Assessment of scalp psoriasis
Measured: After approximately 4 weeks
Secondary outcomes (1)
Patient's Quality of Life
Measured: After approximately 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scalp PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 724 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ulrich Mrowietz, MD, Principal investigator, University Clinic Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01052467
- Sponsor's protocol ID
- Treatment with Xamiol® Gel
- Status last verified
- Sep 2010
- First submitted
- 19 Jan 2010
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Treatment of Scalp Psoriasis With the Fixed Combination of Calcipotriol and Betamethason (Xamiol® Gel)
- ClinicalTrials.gov ID
- NCT01052467
- Acronym / sponsor ID
- Treatment with Xamiol® Gel
- Conditions
- Scalp Psoriasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 724 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 20 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients visiting their attending dermatologist in the primary care clinic
Key inclusion criteria (1 listed)
- Patients with scalp psoriasis if a treatment with Xamiol® gel is planned anyway
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xamiol® GelOnce daily application for about 4 weeks | Drug | – |
Primary outcome
Physician's Global Assessment of scalp psoriasis
Time frame: After approximately 4 weeks
1 secondary outcome
Patient's Quality of Life
Time frame: After approximately 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Scalp Psoriasis
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Immune Spatial Features of Guselkumab Cutaneous Response
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrich Mrowietz, MD principal investigator
University Clinic Schleswig-Holstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scalp Psoriasis, run by LEO Pharma at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician's Global Assessment of scalp psoriasis (time frame: After approximately 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.