Clinical trial NCT05282771: 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.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Plaque Psoriasis
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2022-03-16
Enrollment: 402
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The percentage of subjects with a response of "treatment success" on the IGA of disease severity at Week 8
timeFrame: Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Catawba Research, LLC
state: North Carolina
Study officials:
affiliation: Catawba Research
name: Zaidoon A. Al-Zubaidy
role: STUDY_DIRECTOR
References: