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

Plaque Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01707368
• Other study ID #: DE-Daivobet-longterm-NIS-2012
• Status: Completed
• Start date: October 2012
• Est. completion date: July 2014

Study information

• Verified date: January 2018
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 561
• Est. completion date: July 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis
• Psoriasis Vulgaris

Intervention

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.

Locations

Country	Name	City	State
Germany	PD Dr. med. Rosenbach	Osnabrück	Niedersachsen

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity)	6--point verbal rating scale	Baseline
Secondary	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
Secondary	Side Effects	Number of participants with serious and non-serious adverse drug reactions.	1 year