drugset
drugset / Trial / NCT02668692

LEO 80185 Gel (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Japanese Subjects With Psoriasis

NCT02668692 ↗

Phase 3 Completed 213 enrolled LEO Pharma CMIC Co, Ltd. Japan · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

To compare the efficacy and safety of LEO 80185 gel with Dovobet® ointment in the treatment of psoriasis in Japanese subjects.

Timeline

Start
2016-02
Primary completion
2016-06
Completion
2016-06

Outcome

Missed primary endpoint

registry analysis (superiority test); LEO 80185 Gel vs Dovobet® Ointment; p =0.68; Odds Ratio (OR) 1.96 (95% CI 0.35 to 10.95); Fisher Exact NCT02668692 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Calcipotriol Small molecule 50 unknown Topical
Subject betamethasone dipropionate Small molecule 0.643 unknown Topical

Indications

psoriasis