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Non-interventional Study of Long-term Treatment of Psoriasis With Calcipotriol Plus Betamethasone in Gel Formulation

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.
 
ClinicalTrials.gov Identifier: NCT01707368
Recruitment Status : Completed
First Posted : October 16, 2012
Results First Posted : September 24, 2018
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Study Description
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Brief Summary:
The purpose of this observational study is to document the course of disease and relapse management during treatment with Daivobet® Gel under consideration of patient's individual application habits under daily use conditions.

Condition or disease Intervention/treatment
Psoriasis Vulgaris Plaque Psoriasis Drug: Daivobet® Gel

Study Design
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Study Type : Observational
Actual Enrollment : 561 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Course of Psoriasis During Long Term Treatment With Calcipotriol Plus Betamethasone in Gel Formulation
Study Start Date : October 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Daivobet

Groups and Cohorts
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Group/Cohort Intervention/treatment
all eligible patients
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. The Course of Disease and Relapse Management During Treatment With Daivobet® Gel Under Consideration of Patient's Individual Application Habits Under Daily Use Conditions. [ Time Frame: 1 year ]
    Number of exacerbations and relapses during one year observation time


Secondary Outcome Measures :
  1. PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity) [ Time Frame: Baseline ]
    6--point verbal rating scale

  2. PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity) [ Time Frame: 1 year ]
    Assessment on 6-step scale from "no visible disease (O)" to "very severe disease (5)

  3. Side Effects [ Time Frame: 1 year ]
    Number of participants with serious and non-serious adverse drug reactions.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with Psoriasis vulgaris 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.
  • Minimum of 3 years diagnosed psoriasis vulgaris.

Exclusion Criteria:

  • Previous therapy with Daivobet® Gel
  • Systemic therapy of psoriasis vulgaris
  • Contraindications of Daivobet® Gel in the German package insert
  • people that are incapable to give free consent
Contacts and Locations
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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): NCT01707368


Locations
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Germany
PD Dr. med. Rosenbach
Osnabrück, Niedersachsen, Germany, 49078
Sponsors and Collaborators
LEO Pharma
Investigators
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Principal Investigator: Thomas Rosenberg, PD Dr. med. private practise, D- 49078 Osnabrück, Germany
More Information
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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01707368    
Other Study ID Numbers: DE-Daivobet-longterm-NIS-2012
First Posted: October 16, 2012    Key Record Dates
Results First Posted: September 24, 2018
Last Update Posted: September 24, 2018
Last Verified: January 2018
Keywords provided by LEO Pharma:
Psoriasis
Psoriasis vulgaris
Plaque Psoriasis
Daivobet® Gel
Germany
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases