Status:
COMPLETED
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.
Lead Sponsor:
Sun Pharmaceutical Industries, Inc.
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 tazarot...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 10 2022
Estimated Enrollment :
402 Patients enrolled
Trial Details
Trial ID
NCT05282771
Start Date
April 16 2021
End Date
February 10 2022
Last Update
March 16 2022
Active Locations (1)
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1
Catawba Research, LLC
Charlotte, North Carolina, United States, 28217