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

NCT ID: NCT01707368

Last Updated: 2018-09-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 561 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-07-31

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.

Conditions

Psoriasis Vulgaris; Plaque Psoriasis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Daivobet® Gel

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Rosenberg, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

private practise, D- 49078 Osnabrück, Germany

Locations

PD Dr. med. Rosenbach

Osnabrück, Lower Saxony, Germany

Countries

Germany

Other Identifiers

DE-Daivobet-longterm-NIS-2012

Identifier Type: -

Identifier Source: org_study_id