Plaque PsoriasisEarly Phase 1NCT05282771
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.
A Early Phase 1 study testing Halobetasol Propionate and Tazarotene Lotion 0.01%/0.045% and Duobrii® Lotion (Halobetasol propionate and tazarotene lotion), 0.01%/0.045% in people with Plaque Psoriasis, run by Sun Pharmaceutical Industries, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Halobetasol Propionate and Tazarotene Lotion 0.01%/0.045% and Duobrii® Lotion (Halobetasol propionate and tazarotene lotion), 0.01%/0.045%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 402 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2021to 10 Feb 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Catawba Research, LLC
Charlotte, North Carolina, 28217
About this study
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
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.
Read the 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.
- Conditions
- Plaque Psoriasis
- Being tested
- Halobetasol Propionate and Tazarotene Lotion 0.01%/0.045%, Duobrii® Lotion (Halobetasol propionate and tazarotene lotion), 0.01%/0.045%, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Halobetasol Propionate and Tazarotene Lotion 0.01%/0.045%Drug
Also called Test Product
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.
Duobrii® Lotion (Halobetasol propionate and tazarotene lotion), 0.01%/0.045%Drug
Also called Reference Product
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.
PlaceboDrug
Also called Vehicle
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.
| Study group | Role | What they receive |
|---|---|---|
| Halobetasol Propionate and Tazarotene Topical lotion 0.01%/0.045% | Experimental | 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 Receives: Drug: Halobetasol Propionate and Tazarotene Lotion 0.01%/0.045% |
| Duobrii® Lotion (Halobetasol propionate and tazarotene lotion), 0.01%/0.045% | Active comparator | 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 Receives: Drug: Duobrii® Lotion (Halobetasol propionate and tazarotene lotion), 0.01%/0.045% |
| Placebo Control | Placebo comparator | 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of subjects with a response of "treatment success" on the IGA of disease severity at Week 8
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start16 Apr 2021
- Primary completion10 Feb 2022
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zaidoon A. Al-Zubaidy, Study director, Catawba Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282771
- Sponsor's protocol ID
- HLBT-2001
- Status last verified
- Mar 2022
- First submitted
- 8 Mar 2022
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05282771
- Acronym / sponsor ID
- HLBT-2001
- Conditions
- Plaque Psoriasis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Apr 2021 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Halobetasol Propionate and Tazarotene Topical lotion 0.01%/0.045% | Experimental | Drug: Halobetasol Propionate and Tazarotene Lotion 0.01%/0.045%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 |
| Duobrii® Lotion (Halobetasol propionate and tazarotene lotion), 0.01%/0.045% | Active comparator | Drug: Duobrii® Lotion (Halobetasol propionate and tazarotene lotion), 0.01%/0.045%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 |
| Placebo Control | Placebo comparator | Drug: PlaceboThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Halobetasol Propionate and Tazarotene Lotion 0.01%/0.045%Also: Test ProductThe 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. | Drug | Halobetasol Propionate and Tazarotene Topical lotion 0.01%/0.045% |
| Duobrii® Lotion (Halobetasol propionate and tazarotene lotion), 0.01%/0.045%Also: Reference ProductThe 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. | Drug | Duobrii® Lotion (Halobetasol propionate and tazarotene lotion), 0.01%/0.045% |
| PlaceboAlso: VehicleThe 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. | Drug | Placebo Control |
Primary outcome
The percentage of subjects with a response of "treatment success" on the IGA of disease severity at Week 8
Time frame: Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
Related trials for Plaque Psoriasis
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
Not yet recruitingPhase 3
A Study of Zasocitinib in Adults With Non-pustular Palmoplantar Psoriasis
Palmoplantar Psoriasis
RecruitingPhase 4
A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)
Psoriasis, Overweight or Obesity
Active, not recruitingPhase 3
A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zaidoon A. Al-Zubaidy study director
Catawba Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Halobetasol Propionate and Tazarotene Lotion 0.01%/0.045% and Duobrii® Lotion (Halobetasol propionate and tazarotene lotion), 0.01%/0.045% in people with Plaque Psoriasis, run by Sun Pharmaceutical Industries, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of subjects with a response of "treatment success" on the IGA of disease severity at Week 8 (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.