At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Study Comparing a Gel Containing Calcipotriol 50 mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) With Tacalcitol Ointment (4 mcg/g) and Gel Vehicle, Used Once Daily in the Treatment of Psoriasis Vulgaris
In Brief
A Phase 3 clinical trial evaluating calcipotriol and betamethasone (LEO 80185 gel), LEO 80185 vehicle, and 1 other intervention for Psoriasis Vulgaris. Completed, enrolled 458 participants across 1 site.
Detailed Summary
This study will compare efficacy and safety of once daily treatment of calcipotriol plus betamethasone dipropionate gel (LEO 80185) with tacalcitol ointment and LEO 80185 vehicle alone in subjects with psoriasis vulgaris. Subjects will be treated for up to 8 weeks followed by an observation period of up to 8 weeks to investigate the occurence and the time to relapse and occurence of rebound after discontinuation of the investigational products. Only subjects with "controlled disease" will be considered for this observation phase of the study. "Controlled disease" is defined as "Clear" or "Almost Clear" severity category based on Investigator's global assessment (IGA).
Study Details
Timeline
Interventions
Once daily application
Once daily application
Once daily application