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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT01707368
First received: October 12, 2012
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

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 Intervention
Psoriasis Vulgaris
Plaque Psoriasis
Drug: Daivobet® Gel

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Course of Psoriasis During Long Term Treatment With Calcipotriol Plus Betamethasone in Gel Formulation

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Number of exacerbations and relapses during one year observation time


Secondary Outcome Measures:
  • Physician's global Assessment of psoriasis vulgaris [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Assessment on 6-step scale from "no visible disease (O)" to "very severe disease (5)

  • Side effects [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Number of participants with serious and non-serious adverse drug reactions, according to organ classes.


Estimated Enrollment: 1000
Study Start Date: October 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01707368

Locations
Germany
PD Dr. med. Rosenbach
Osnabrück, Niedersachsen, Germany, 49078
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Thomas Rosenberg, PD Dr. med. private practise, D- 49078 Osnabrück, Germany
  More Information

No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01707368     History of Changes
Other Study ID Numbers: DE-Daivobet-longterm-NIS-2012
Study First Received: October 12, 2012
Last Updated: November 22, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by LEO Pharma:
Psoriasis
Psoriasis vulgaris
Plaque Psoriasis
Daivobet® Gel
Germany

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone sodium phosphate
Calcipotriene
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dermatologic Agents

ClinicalTrials.gov processed this record on April 15, 2014