Topical Treatment of Scalp Psoriasis With the Fixed Combi... | NCT01052467

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

NCT01052467

Sponsor

LEO Pharma

Status

Completed

Last Update Posted

Feb 24, 2025Actual

Enrollment

724Actual

Phase

Not provided

Conditions

Scalp Psoriasis

Interventions

Xamiol® Gel

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

May 2010Actual

Completion Date

May 2010Actual

First Submitted Date

Jan 19, 2010

First Submission Date that Met QC Criteria

Jan 19, 2010

First Posted Date

Jan 20, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2025

Last Update Posted Date

Feb 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

724Actual

Name	Type	Description	Arm Group Labels	Other Names
Xamiol® Gel	Drug	Once daily application for about 4 weeks

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Physician's Global Assessment of scalp psoriasis		After approximately 4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Patient's Quality of Life		After approximately 4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients visiting their attending dermatologist in the primary care clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ulrich Mrowietz, MD	University Clinic Schleswig-Holstein	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Clinical Schleswig-Holstein, Campus Kiel		Kiel		24105	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided