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 Phase 1

Completed

• Conditions: Plaque Psoriasis
• Interventions: Drug: Halobetasol Propionate and Tazarotene Lotion 0.01%/0.045%; Drug: Placebo; Drug: Duobrii® Lotion (Halobetasol propionate and tazarotene lotion), 0.01%/0.045%

• Registration Number: NCT05282771
• Lead Sponsor: Taro Pharmaceuticals USA

Brief 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.

Detailed Description

A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Halobetasol Propionate and Tazarotene Topical Lotion 0.01%/0.045% (Taro Pharmaceuticals U.S.A., Inc.) and Duobrii® Lotion (Halobetasol propionate and tazarotene lotion), 0.01%/0.045% (Reference Listed Drug) in the Treatment of Moderate to Severe Plaque Psoriasis.

Study Timeline

• Study Start: 2021-04-16
• Primary Completion: 2022-02-10
• Study Completion: 2022-02-10
• Status Verified: 2022-03
• Study First Submitted: 2022-03-08
• Study First Submitted QC: 2022-03-15
• Last Update Submitted: 2022-03-15
• Study First Posted: 2022-03-16
• Last Update Posted: 2022-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 402

Inclusion Criteria

• Healthy male or non-pregnant female aged ≥ 18 years
• Subjects must have provided IRB approved written informed consent
• Subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits
• Subjects with a clinical diagnosis of stable (at least 6 months) plaque psoriasis involving at least 3% and no more than 12% of the body surface area (BSA). Affected areas should not include the axillae, face, scalp, soles, palms, and intertriginous areas

Exclusion Criteria

• Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
• Females of childbearing potential who do not agree to utilize an adequate form of contraception.
• Subjects with a known hypersensitivity to tazarotene, halobetasol propionate, other corticosteroids, or to any ingredients in the study drugs.
• Subjects with current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Halobetasol Propionate and Tazarotene Topical lotion 0.01%/0.045%	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
Placebo Control	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
Duobrii® Lotion (Halobetasol propionate and tazarotene lotion), 0.01%/0.045%	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

Primary Outcome Measures

Name	Time	Method
The percentage of subjects with a response of "treatment success" on the IGA of disease severity at Week 8	Week 8

Trial Locations

Locations (1)

Catawba Research, LLC; 🇺🇸 Charlotte, North Carolina, United States