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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
History of Changes
  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:

MedlinePlus related topics: Psoriasis
Drug Information available for: Daivobet
U.S. FDA Resources

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
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 May 21, 2013