This single arm study will evaluate the efficacy and safety of sequential treatment with Diavobet (betamethasone propionate 0.5mg/g plus calcipotriol hydrate 50 micrograms/g) once daily for 4 weeks followed by Daivonex (calcipotriol hydrate 50 micrograms/g) twice daily for 4 weeks, in the control of signs and symptoms in patients with mild to moderate psoriasis. Only patients showing a >50% response to Daivobet will progress to the Daivonex maintenance phase. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.
Full Title of Study: “An Open Label Study to Evaluate the Clinical Response to Sequential Treatment With Daivobet and Daivonex in Patients With Mild to Moderate Psoriasis”
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: August 2009
- Drug: calcipotriol hydrate [Daivonex]
- 50 micrograms/g bid for 4 weeks (weeks 5-8) in patients who have shown a >50% response to Daivobet from weeks 0-4.
Arms, Groups and Cohorts
- Experimental: 1
Clinical Trial Outcome Measures
- PASI reduction
- Time Frame: Weeks 4 and 8
- Time Frame: Throughout study
Participating in This Clinical Trial
- adult patients >=18 years of age;
- clinical diagnosis of psoriasis vulgaris;
- PASI score 1-12 in >=1 body area.
- clinical presentation of erythrodermic pustular psoriasis, expressed in plates and localized lesions on face and/or scalp;
- viral, fungal or bacterial skin infections;
- use of any topical treatment for psoriasis within previous 15 days;
- use of any systemic therapy and phototherapy for psoriasis within previous 30 days.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Hoffmann-La Roche
- Provider of Information About this Clinical Study
- Overall Official(s)
- Clinical Trials, Study Director, Hoffmann-La Roche
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