drugset / Trial / NCT00216840

Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel in Scalp Psoriasis

NCT00216840 ↗

Phase 3 Completed 1350 enrolled LEO Pharma
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of the study is to evaluate whether once daily topical treatment for up to 8 weeks of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel is safe and more effective than betamethasone 0.5 mg/g (as dipropionate) in the gel vehicle and calcipotriol 50 mcg/g in the gel vehicle in patients with scalp psoriasis. The primary response criterion is the number of patients with absence of disease and very mild disease after 8 weeks of treatment.

Timeline

Start
2004-12
Primary completion
—
Completion
2005-09

Outcome

Met primary endpoint

paper The proportion of patients with 'absence of disease' or 'very mild disease' at week 8 was significantly higher in the two-compound group (68.4%) than PMID 19067709 ↗

paper than the betamethasone dipropionate (61.0%, P = 0.0079) or calcipotriol (43.4%, P < 0.0001) groups. PMID 19067709 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Calcipotriol Small molecule 50 unknown Topical
Subject betamethasone dipropionate Small molecule 0.5 unknown Topical

Indications