Efficacy, Tolerability and Handling of Daivobet® Gel in Patients With Psoriasis Vulgaris

Psoriasis Vulgaris Clinical Trial

Official title:

Efficacy, Tolerability and Handling of Daivobet® Gel in Patients With Psoriasis Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01320774
• Other study ID #: Treatment with Daivobet® Gel
• Status: Completed
• Phase: N/A
• First received: March 18, 2011
• Last updated: February 9, 2012
• Start date: April 2011
• Est. completion date: January 2012

Study information

• Verified date: February 2012
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

The purpose of this observational study is to evaluate the efficacy, tolerability, quality of life and handling of Daivobet® Gel by both physician and patient in daily practise.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 588
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• 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

Exclusion Criteria:

• Previous therapy with Daivobet® Gel

• Systemic therapy of psoriasis vulgaris

• Contraindications of Daivobet® Gel in the German package insert

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• 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	University Clinic of Erlangen Nuernberg	Erlangen

Sponsors (2)

Lead Sponsor	Collaborator
LEO Pharma	LEO Pharma GmbH, Neu-Isenburg, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Handling of Daivobet® Gel	Compared to previous topical treatment: Time required for application (previous treatment versus present treatment), time required until dressing is possible (previous treatment versus present treatment)	After appr 4 weeks	No
Secondary	Quality of life	Dermatology Life Quality Index (DLQI)	4 weeks	No
Secondary	Physician's global Assessment of psoriasis vulgaris	6-step scale from "no visible disease (O)" to "very severe disease (5)	4 weeks	No
Secondary	Side effects	number of participants with serious and non-serious adverse drug reactions, according to organ classes	4 weeks	Yes