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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.

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.) to Duobrii® Lotion (Halobetasol Propionate and Tazarotene Lotion), 0.01%/0.045% (Reference Listed Drug) and Both Active Treatments to a Placebo Control in the Treatment of Moderate to Severe Plaque Psoriasis

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05282771
Enrollment
402
Registered
2022-03-16
Start date
2021-04-16
Completion date
2022-02-10
Last updated
2022-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque Psoriasis

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.

Interventions

DRUGHalobetasol 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.

DRUGDuobrii® 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.

DRUGPlacebo

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

Sun Pharmaceutical Industries, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026