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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01320774
First Posted: March 22, 2011
Last Update Posted: February 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
LEO Pharma GmbH, Neu-Isenburg, Germany
Information provided by (Responsible Party):
LEO Pharma
  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 ]
    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 ]
    Dermatology Life Quality Index (DLQI)

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

  • Side effects [ Time Frame: 4 weeks ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01320774     History of Changes
Other Study ID Numbers: Treatment with Daivobet® Gel
First Submitted: March 18, 2011
First Posted: March 22, 2011
Last Update Posted: February 10, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Betamethasone
Calcitriol
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Growth Substances
Bone Density Conservation Agents


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