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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 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 402

Last updated 2022-03-16

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Sun Pharmaceutical Industries, Inc.

    lead INDUSTRY

Principal Investigators

  • Zaidoon A. Al-Zubaidy · Catawba Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-16
Primary Completion
2022-02-10
Completion
2022-02-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05282771 on ClinicalTrials.gov