Psoriasis Clinical Trial

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.

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.

View Full Description

Full 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.

View Eligibility Criteria

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.

Study is for people with:

Psoriasis

Phase:

Early Phase 1

Estimated Enrollment:

402

Study ID:

NCT05282771

Recruitment Status:

Completed

Sponsor:

Taro Pharmaceuticals USA

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There is 1 Location for this study

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Catawba Research, LLC
Charlotte North Carolina, 28217, United States

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Early Phase 1

Estimated Enrollment:

402

Study ID:

NCT05282771

Recruitment Status:

Completed

Sponsor:


Taro Pharmaceuticals USA

How clear is this clinincal trial information?

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