NCT01610596

A Study to Determine the Efficacy and Safety of Halobetasol Propionate Lotion 0.05% in Subjects With Plaque Psoriasis

A Double-blind, Randomized, Multicenter, Vehicle-Controlled Parallel Group Study to Determine the Efficacy and Safety of Halobetasol Propionate Lotion 0.05% in Subjects With Plaque Psoriasis Receiving Two Weeks of Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a double-blind, multicenter, vehicle-controlled, parallel group comparison study to determine and compare the efficacy and safety of HBP Lotion 0.05% and Vehicle Lotion applied twice daily for two weeks in subjects with moderate to severe plaque psoriasis. Eligible subjects will be randomized (1:1) to one of two treatment groups - HBP Lotion 0.05% or Vehicle Lotion. The maximum amount of test article to be applied per week should not exceed 50 grams.

Conditions

• Psoriasis
• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	Halobetasol Propionate Lotion 0.05%	Apply twice daily for 1-2 weeks, not to exceed 50 grams per week
DRUG	Placebo

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2012-06-04
• Last updated: 2016-05-13
• Results posted: 2016-04-11

Locations

3 sites across 1 country: United States