Chronic localized Psoriasis vulgaris MedDRA version: 9.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris
Conditions
Interventions
Trade Name: Dovobet
Product Name: Dovobet
Pharmaceutical Form: Ointment
INN or Proposed INN: CALCIPOTRIOL
CAS Number: 112828009
Concentration unit: µg microgram(s)
Concentration type: equal
Concentrat
Sponsors
University Medical Centre St Radboud, Department of Dermatology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy psoriasispatients from 18-80 years Mild to moderate stabile plaque psoriasis with at least two plaques measuring 10 cm2 unresponsive to conventional topical treatment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pregnancy or lactating No use of contraceptives Treatment with systemic psoriasismedication or UVB-PUVA exposure 4 weeks prior to baseline Treatment with topical steroids or vitamine D derivatives 2 weeks prior to baseline Psoriasis pustulosa or erythordermic psoriasis Impetiginisation of psoriatic lesions History of sunlight reactivity Surgery or holiday planned in treatment period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To elucidate and describe the clinical effectiveness of Dovobet ointment compared to treatment with a Nd YAG laser in psoriasispatients;Secondary Objective: Evaluation of pain during and after treatment with the Nd YAG laser using the Visual Analog Scale (0-10) to rate the pain. ;Primary end point(s): Rate of clearance after 3 months of treatment | — |
Countries
Netherlands
Outcome results
None listed