A Phase 4 interventional study of calcipotriol hydrate [Daivonex] in Psoriasis, sponsored by Hoffmann-La Roche. Completed at 10 sites in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-02.
Sponsored by Hoffmann-La Roche · Phase 4, Interventional, and Treatment
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.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 200 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
PASI reduction
Time frame: Weeks 4 and 8
AEs.
Time frame: Throughout study
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche