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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

March 18, 2011
February 9, 2012
April 2011
January 2012   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01320774 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Efficacy, Tolerability and Handling of Daivobet® Gel in Patients With Psoriasis Vulgaris
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients visiting their attending dermatologist in the primary care clinic
Psoriasis Vulgaris
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
588
January 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01320774
Treatment with Daivobet® Gel
No
LEO Pharma
LEO Pharma
LEO Pharma GmbH, Neu-Isenburg, Germany
Principal Investigator: Michael Sticherling, Prof dr med University clinic Erlangen-Nuernberg
LEO Pharma
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP