A Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis (Study 310)

Phase 3 Completed 409 enrolled Therapeutics, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This Phase 3 study (Study 310) has been designed to determine and compare the efficacy and safety of 122-0551 Foam and Vehicle Foam applied twice daily for two weeks in subjects with plaque psoriasis.

Timeline

Start: 2016-06
Primary completion: 2017-02-27
Completion: 2017-06-16

Outcome

Met primary endpoint

registry NUMBER 122-0551 Foam: 30.7 percentage of participants NUMBER Vehicle Foam: 7.4 percentage of participants analysis (superiority test); 122-0551 Foam vs Vehicle Foam; p <0.001; NCT02742441 ↗

Publications

Bhatia N, Stein Gold L, Kircik LH, Schreiber R. Two Multicenter, Randomized, Double-Blind, Parallel Group Comparison Studies of a Novel Foam Formulation of Halobetasol Propionate, 0.05% vs Its Vehicle in Adult Subjects With Plaque Psoriasis. J Drugs Dermatol. 2019 Aug 1;18(8):790-796.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	halobetasol propionate	Small molecule	0.05 %	Topical