drugset / Trial / NCT03731091

To Study Generic Calcipotriene and Betamethasone Dipropionate Topical Foam, 0.005%/0.064%, in the Treatment of Psoriasis Vulgaris (Plaque Psoriasis).

NCT03731091

Phase 3 Completed 494 enrolled Glenmark Pharmaceuticals Ltd. India
RandomizedParallel-groupQuadruple-blindTreatment

Summary

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Calcipotriene and Betamethasone Dipropionate Topical Foam, 0.005%/0.064% (Glenmark Pharmaceuticals Ltd) to the Marketed Product Enstilar® Foam (LEO Pharma Inc.) in the Treatment of Psoriasis Vulgaris (Plaque Psoriasis)

Timeline

Start
2018-10-31
Primary completion
2020-03-17
Completion
2020-03-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Calcipotriol Small molecule 0.005 % Topical
Comparator Enstilar Unknown
Subject betamethasone dipropionate Small molecule 0.064 % Topical

Indications