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

This study has been completed.
Sponsor:
Collaborator:
LEO Pharma GmbH, Neu-Isenburg, Germany
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT01320774
First received: March 18, 2011
Last updated: February 9, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Psoriasis Vulgaris
Drug: Daivobet® Gel

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy, Tolerability and Handling of Daivobet® Gel in Patients With Psoriasis Vulgaris

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • Handling of Daivobet® Gel [ Time Frame: After appr 4 weeks ] [ Designated as safety issue: No ]
    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:
  • Quality of life [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Dermatology Life Quality Index (DLQI)

  • Physician's global Assessment of psoriasis vulgaris [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    6-step scale from "no visible disease (O)" to "very severe disease (5)

  • Side effects [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    number of participants with serious and non-serious adverse drug reactions, according to organ classes


Enrollment: 588
Study Start Date: April 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients visiting their attending dermatologist in the primary care clinic

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01320774

Locations
Germany
University Clinic of Erlangen Nuernberg
Erlangen, Germany, 91054
Sponsors and Collaborators
LEO Pharma
LEO Pharma GmbH, Neu-Isenburg, Germany
Investigators
Principal Investigator: Michael Sticherling, Prof dr med University clinic Erlangen-Nuernberg
  More Information

No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01320774     History of Changes
Other Study ID Numbers: Treatment with Daivobet® Gel
Study First Received: March 18, 2011
Last Updated: February 9, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on August 25, 2014