Non-interventional Study of Long-term Treatment of Psoriasis With Calcipotriol Plus Betamethasone in Gel Formulation

Course of Psoriasis During Long Term Treatment With Calcipotriol Plus Betamethasone in Gel Formulation

The purpose of this observational study is to document the course of disease and relapse management during treatment with Daivobet® Gel under consideration of patient's individual application habits under daily use conditions.

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis; Psoriasis Vulgaris
• Intervention / Treatment: Drug: Daivobet® Gel

• Study Type: Observational
• Enrollment (Actual): 561

Contacts and Locations

Study Locations

• Germany
  • Niedersachsen
    • Osnabrück, Niedersachsen, Germany, 49078
      • PD Dr. med. Rosenbach

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with Psoriasis vulgaris visiting their attending dermatologist in the primary care clinic

Description

Inclusion Criteria:

• Patients with light to moderate psoriasis vulgaris of trunk and extremities and treatment with Daivobet® Gel was planned anyway.
• Minimum of 3 years diagnosed psoriasis vulgaris.

Exclusion Criteria:

• Previous therapy with Daivobet® Gel
• Systemic therapy of psoriasis vulgaris
• Contraindications of Daivobet® Gel in the German package insert
• people that are incapable to give free consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
all eligible patients; Daivobet® Gel once daily on areas with plaque psoriasis, treatment duration up to 8 weeks for body skin areas except scalp (scalp up to 4 weeks), treatment may be repeated under medical surveillance.	Drug: Daivobet® Gel; Once daily on areas with plaque psoriasis, treatment duration up to 8 weeks for body skin areas except scalp (scalp up to 4 weeks), treatment may be repeated under medical surveillance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Course of Disease and Relapse Management During Treatment With Daivobet® Gel Under Consideration of Patient's Individual Application Habits Under Daily Use Conditions.	Number of exacerbations and relapses during one year observation time	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity)	6--point verbal rating scale	Baseline
PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity)	Assessment on 6-step scale from "no visible disease (O)" to "very severe disease (5)	1 year
Side Effects	Number of participants with serious and non-serious adverse drug reactions.	1 year

Collaborators and Investigators

• Sponsor: LEO Pharma
• Investigators: Principal Investigator: Thomas Rosenberg, PD Dr. med., private practise, D- 49078 Osnabrück, Germany

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (ACTUAL): May 1, 2014
• Study Completion (ACTUAL): July 1, 2014

Study Registration Dates

• First Submitted: October 12, 2012
• First Submitted That Met QC Criteria: October 12, 2012
• First Posted (ESTIMATE): October 16, 2012

Study Record Updates

• Last Update Posted (ACTUAL): September 24, 2018
• Last Update Submitted That Met QC Criteria: January 24, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Psoriasis; Plaque Psoriasis; Psoriasis vulgaris; Germany; Daivobet® Gel
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: DE-Daivobet-longterm-NIS-2012