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

Completed

• Conditions: Psoriasis Vulgaris; Plaque Psoriasis
• Interventions: Drug: Daivobet® Gel

• Registration Number: NCT01707368
• Lead Sponsor: LEO Pharma

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-12
• Study First Submitted QC: 2012-10-12
• Study First Posted: 2012-10-16
• Primary Completion: 2014-05
• Study Completion: 2014-07
• Status Verified: 2018-01
• Results First Submitted: 2018-01-24
• Results First Submitted QC: 2018-01-24
• Last Update Submitted: 2018-01-24
• Results First Posted: 2018-09-24
• Last Update Posted: 2018-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 561

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
all eligible patients	Daivobet® Gel	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

PD Dr. med. Rosenbach; 🇩🇪 Osnabrück, Niedersachsen, Germany