Back to resultsA 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.
Primary Purpose
Plaque Psoriasis
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Halobetasol Propionate and Tazarotene Lotion 0.01%/0.045%
Duobrii® Lotion (Halobetasol propionate and tazarotene lotion), 0.01%/0.045%
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for 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.
Sites / Locations
- Catawba Research, LLC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Halobetasol Propionate and Tazarotene Topical lotion 0.01%/0.045%
Duobrii® Lotion (Halobetasol propionate and tazarotene lotion), 0.01%/0.045%
Placebo Control
Arm Description
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
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
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
Outcomes
Primary Outcome Measures
The percentage of subjects with a response of "treatment success" on the IGA of disease severity at Week 8
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05282771
Brief Title
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 16, 2021 (Actual)
Primary Completion Date
February 10, 2022 (Actual)
Study Completion Date
February 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taro Pharmaceuticals USA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
402 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Halobetasol Propionate and Tazarotene Topical lotion 0.01%/0.045%
Arm Type
Experimental
Arm Description
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
Arm Title
Duobrii® Lotion (Halobetasol propionate and tazarotene lotion), 0.01%/0.045%
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo Control
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Halobetasol Propionate and Tazarotene Lotion 0.01%/0.045%
Other Intervention Name(s)
Test Product
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Duobrii® Lotion (Halobetasol propionate and tazarotene lotion), 0.01%/0.045%
Other Intervention Name(s)
Reference Product
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Vehicle
Intervention Description
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.
Primary Outcome Measure Information:
Title
The percentage of subjects with a response of "treatment success" on the IGA of disease severity at Week 8
Time Frame
Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zaidoon A. Al-Zubaidy
Organizational Affiliation
Catawba Research
Official's Role
Study Director
Facility Information:
Facility Name
Catawba Research, LLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28217
Country
United States
12. IPD Sharing Statement
Learn more about this 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.
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