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 | Completed Early Phase 1 FDA Drug

• 1 other identifier: HLBT-2001
• Study Type: interventional
• Target: 402
• Locations: 1 country
• Sites: 1

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.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

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

  Week 8

Study Arms (3)

Halobetasol Propionate and Tazarotene Topical lotion 0.01%/0.045%

EXPERIMENTAL

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: Halobetasol Propionate and Tazarotene Lotion 0.01%/0.045%

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

ACTIVE COMPARATOR

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%

Placebo Control

PLACEBO COMPARATOR

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

Interventions

Halobetasol Propionate and Tazarotene Lotion 0.01%/0.045% 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.

Also known as: Test Product

Halobetasol Propionate and Tazarotene Topical lotion 0.01%/0.045%

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

Also known as: Reference Product

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

Placebo 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.

Also known as: Vehicle

Placebo Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Pharmaceutical Industries, Inc.: lead

Study Sites (1)

Catawba Research, LLC

Charlotte, North Carolina, 28217, United States

Location

MeSH Terms

Interventions

halobetasol

Study Officials

• Zaidoon A. Al-Zubaidy

  Catawba Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 16, 2022
• Study Start: April 16, 2021
• Primary Completion: February 10, 2022
• Study Completion: February 10, 2022
• Last Updated: March 16, 2022

Record last verified: 2022-03

Locations

US (1)