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.

NCT ID: NCT05282771

Last Updated: 2022-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 402 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-16
• Study Completion Date: 2022-02-10

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.

Conditions

Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Halobetasol Propionate and Tazarotene Topical 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

Group Type: EXPERIMENTAL

Halobetasol Propionate and Tazarotene Lotion 0.01%/0.045%

Intervention Type: DRUG

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%

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Test Product; Reference Product; Vehicle

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sun Pharmaceutical Industries, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zaidoon A. Al-Zubaidy

Role: STUDY_DIRECTOR

Catawba Research

Locations

Catawba Research, LLC

Charlotte, North Carolina, United States

Countries

United States

Other Identifiers

HLBT-2001

Identifier Type: -

Identifier Source: org_study_id