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
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, see Learn About Clinical Studies.

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 July 26, 2014