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.

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

402

Participants

Timeline

Start Date

April 16, 2021

Primary Completion Date

February 10, 2022

Study Completion Date

February 10, 2022

Conditions
Plaque Psoriasis
Interventions
DRUG

Halobetasol Propionate and Tazarotene Lotion 0.01%/0.045%

The study drug is to be self-administered by applying as a thin layer once daily to cover only affected areas and rubbed in gently for approximately 8 weeks.

DRUG

Duobrii® Lotion (Halobetasol propionate and tazarotene lotion), 0.01%/0.045%

The study drug is to be self-administered by applying as a thin layer once daily to cover only affected areas and rubbed in gently for approximately 8 weeks.

DRUG

Placebo

The study drug is to be self-administered by applying as a thin layer once daily to cover only affected areas and rubbed in gently for approximately 8 weeks.

Trial Locations (1)

28217

Catawba Research, LLC, Charlotte

All Listed Sponsors
lead

Sun Pharmaceutical Industries, Inc.

INDUSTRY