NCT01320774

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
588

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 22, 2011

Completed
10 days until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

February 10, 2012

Status Verified

February 1, 2012

Enrollment Period

9 months

First QC Date

March 18, 2011

Last Update Submit

February 9, 2012

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

  • Handling of Daivobet® Gel

    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)

    After appr 4 weeks

Secondary Outcomes (3)

  • Quality of life

    4 weeks

  • Physician's global Assessment of psoriasis vulgaris

    4 weeks

  • Side effects

    4 weeks

Interventions

Daivobet® GelDRUG

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 Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients visiting their attending dermatologist in the primary care clinic

You may qualify if:

  • Patients with light to moderate psoriasis vulgaris of trunk and extremities and treatment with Daivobet® Gel was planned anyway

You may not qualify if:

  • Previous therapy with Daivobet® Gel
  • Systemic therapy of psoriasis vulgaris
  • Contraindications of Daivobet® Gel in the German package insert

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinic of Erlangen Nuernberg

Erlangen, 91054, Germany

Location

Study Officials

  • Michael Sticherling, Prof dr med

    University clinic Erlangen-Nuernberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2011

First Posted

March 22, 2011

Study Start

April 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

February 10, 2012

Record last verified: 2012-02

Locations

DE(1)