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OpenTrials
Completed

NCT Number: NCT01320774

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

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.

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Key information

Conditions

Psoriasis Vulgaris

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Clinic of Erlangen Nuernberg

Erlangen, 91054, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Daivobet® Gel

Drug

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 outcomes

  1. Handling of Daivobet® Gel

    Time frame: 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 outcomes

  1. Quality of life

    Time frame: 4 weeks

    Dermatology Life Quality Index (DLQI)

  2. Physician's global Assessment of psoriasis vulgaris

    Time frame: 4 weeks

    6-step scale from "no visible disease (O)" to "very severe disease (5)

  3. Side effects

    Time frame: 4 weeks

    number of participants with serious and non-serious adverse drug reactions, according to organ classes

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Collaborators

  • LEO Pharma GmbH, Neu-Isenburg, Germany

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 22, 2011
Registry last updated
Feb 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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