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Efficacy, Tolerability and Handling of Daivobet® Gel in Patients With Psoriasis Vulgaris

Efficacy, Tolerability and Handling of Daivobet® Gel in Patients With Psoriasis Vulgaris

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01320774
Enrollment
588
Registered
2011-03-22
Start date
2011-04-30
Completion date
2012-01-31
Last updated
2012-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis Vulgaris

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.

Interventions

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.

Sponsors

LEO Pharma GmbH, Neu-Isenburg, Germany
CollaboratorUNKNOWN
LEO Pharma
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Handling of Daivobet® GelAfter appr 4 weeksCompared to previous topical treatment: Time required for application (previous treatment versus present treatment), time required until dressing is possible (previous treatment versus present treatment)

Secondary

MeasureTime frameDescription
Quality of life4 weeksDermatology Life Quality Index (DLQI)
Physician's global Assessment of psoriasis vulgaris4 weeks6-step scale from no visible disease (O) to very severe disease (5)
Side effects4 weeksnumber of participants with serious and non-serious adverse drug reactions, according to organ classes

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026