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.

• Status: Completed
• Trial end date: 2022-02-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Taro Pharmaceuticals USA
• Treatments: Clobetasol; Halobetasol; Nicotinic Acids; Tazarotene

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.