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

Completed

• Conditions: Psoriasis Vulgaris

• Registration Number: NCT01320774
• Lead Sponsor: LEO Pharma

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-18
• Study First Submitted QC: 2011-03-21
• Study First Posted: 2011-03-22
• Study Start: 2011-04
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-09
• Last Update Posted: 2012-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 588

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Handling of Daivobet® Gel	After appr 4 weeks	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)

Secondary Outcome Measures

Name	Time	Method
Quality of life	4 weeks	Dermatology Life Quality Index (DLQI)
Physician's global Assessment of psoriasis vulgaris	4 weeks	6-step scale from "no visible disease (O)" to "very severe disease (5)
Side effects	4 weeks	number of participants with serious and non-serious adverse drug reactions, according to organ classes

Trial Locations

Locations (1)

University Clinic of Erlangen Nuernberg; 🇩🇪 Erlangen, Germany