drugset / Trial / NCT05282771

A Study Comparing Halobetasol Propionate and Tazarotene Topical Lotion 0.01%/0.045% to Duobrii® Lotion (Halobetasol Propionate and Tazarotene Lotion), 0.01%/0.045% (Reference Listed Drug) in the Treatment of Moderate to Severe Plaque Psoriasis.

NCT05282771

Phase 0 Completed 402 enrolled Sun Pharmaceutical Industries, Inc.
RandomizedParallel-groupSingle-blindTreatment

Summary

To evaluate the therapeutic equivalence and safety of halobetasol propionate and tazarotene topical lotion 0.01%/0.045% (Taro Pharmaceuticals U.S.A., Inc.) and Duobrii® Lotion (halobetasol and tazarotene lotion), 0.01%/0.045% (Reference Listed Drug) in the treatment of moderate to severe plaque psoriasis.

Timeline

Start
2021-04-16
Primary completion
2022-02-10
Completion
2022-02-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Duobrii Unknown 0.01 % Topical
Comparator Duobrii Unknown 0.045 % Topical
Subject halobetasol propionate Small molecule 0.01 % Topical
Subject halobetasol propionate Small molecule 0.045 % Topical

Indications