Non-interventional Study of Long-term Treatment of Psoriasis With Calcipotriol Plus Betamethasone in Gel Formulation
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: October 12, 2012
Last updated: November 22, 2013
Last verified: November 2013
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.
Drug: Daivobet® Gel
||Observational Model: Cohort
Time Perspective: Prospective
||Course of Psoriasis During Long Term Treatment With Calcipotriol Plus Betamethasone in Gel Formulation
Primary Outcome Measures:
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||May 2014 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients with Psoriasis vulgaris visiting their attending dermatologist in the primary care clinic
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01707368
|PD Dr. med. Rosenbach
|Osnabrück, Niedersachsen, Germany, 49078 |
||Thomas Rosenberg, PD Dr. med.
||private practise, D- 49078 Osnabrück, Germany
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 12, 2012
||November 22, 2013
||Germany: Federal Institute for Drugs and Medical Devices
Keywords provided by LEO Pharma:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 05, 2013
Skin Diseases, Papulosquamous
Betamethasone sodium phosphate
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs