Trial information
A Study of Sequential Treatment With Daivobet (Betamethasone Dipropionate plus Calcipotriol) and Daivonex (Calcipotriol) in Patients With Psoriasis.
Status: No longer recruiting
Protocol number: ML19876
Sponsor: Produtos Roche Químicos e Farmacêuticos S.A.
Company division: Pharmaceutical
Official Scientific Title: An open label study to evaluate the clinical response to sequential treatment with Daivobet and Daivonex in patients with mild to moderate psoriasis
Brief summary: 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. Target sample size is
198.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Psoriasis
Intervention type: Drug
Intervention name: Calcipotriol hydrate [Daivonex]
Primary outcome: 1. PASI reduction Time frame: Weeks 4 and 8
Key secondary outcomes: 1. AEs. Time frame: Throughout study
Inclusion criteria:
- adult patients >=18 years of age;
- clinical diagnosis of psoriasis vulgaris;
- PASI score 1-12 in >=1 body area.
Exclusion criteria:
- 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: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: February, 2007
Trial registration date: 02/19/2007
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Brazil
- Belem
- Belo Horizonte
- Botucatu
- Brasilia
- Campinas
- Curitiba
- Rio De Janeiro
- Salvador
- Sao Paulo
