Scalp PsoriasisPhase 1NCT03880357
To Evaluate the Therapeutic Equivalence and Safety in Treatment of Scalp Psoriasis
A Phase 1 study testing Betamethasone Scalp Suspension 0.064%;0.0005% and Taclonex® in people with Scalp Psoriasis, run by Sun Pharmaceutical Industries, Inc. at 1 site in United States.
Trial summary
To demonstrate the superiority of the efficacy of the test and reference products over that of the placebo control in the treatment of scalp psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scalp Psoriasis
- What is being tested?
- Betamethasone Scalp Suspension 0.064%;0.0005% and Taclonex®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 485 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2018to 15 Mar 2019
- Phase
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy male or non-pregnant female aged ≥18 years
- All male subjects had to agree to use accepted methods of birth control with their partners, from the day of the first application of the study drug to 30 days after the last application of the study drug
- Willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits
- A clinical diagnosis of stable (at least 6 months) scalp psoriasis involving at least 10% of the scalp
Who cannot join
- Female subjects who were pregnant, nursing, or planning to become pregnant during study participation
- Known hypersensitivity to calcipotriene, betamethasone dipropionate, other corticosteroids, or to any ingredients in the study drugs
- 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: Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-group Study Comparing Taro Product to RLD and Both Active Treatments to a Placebo Control in the Treatment of Scalp Psoriasis
To demonstrate the superiority of the efficacy of the test and reference products over that of the placebo control in the treatment of scalp psoriasis.
Read the detailed description
Multi-center, double-blind, randomized, placebo controlled, parallel-group study comparing test and reference products to a placebo control in the treatment of scalp psoriasis
- Conditions
- Scalp Psoriasis
- Being tested
- Betamethasone Scalp Suspension 0.064%;0.0005%, Taclonex®, Placebo topical suspension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Betamethasone Scalp Suspension 0.064%;0.0005%Drug
Also called Taclonex
applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks.
Taclonex®Drug
Also called Calcipotriene and Betamethasone Dipropionate
applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks.
Placebo topical suspensionDrug
Also called Vehicle
applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Test Product | Experimental | Betamethasone Scalp Suspension 0.064%;0.0005% (Taro Pharmaceuticals Inc.) Receives: Drug: Betamethasone Scalp Suspension 0.064%;0.0005% |
| Reference Product | Active comparator | Taclonex® (Calcipotriene Hydrate and Betamethasone Dipropionate) Topical suspension 0.005%/0.064% (LEO PHARMA) Receives: Drug: Taclonex® |
| Placebo | Placebo comparator | Vehicle of the test product (Taro Pharmaceuticals Inc.) Receives: Drug: Placebo topical suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment success on the Physician's Global Assessment (PGA) of disease severity
The proportion of subjects in each treatment group with "treatment success" (defined as none or minimal, a score of 0 or 1, within the treatment area) on the PGA of disease severity
Measured: Study Week 4 (Day 28 ± 4 days)
clinical success on the Physician's Global Assessment (PASI) of disease severity
The proportion of subjects in each treatment group with "clinical success" (defined as clear or almost clear, a score of 0 or 1, at the target lesion site) on the PASI. Each psoriatic sign of scaling, erythema and plaque elevation should have a score of 0 or 1 for the subject to be considered a clinical success. The target lesion is to be identified at Baseline as the most severe lesion.
Measured: Study Week 4 (Day 28 ± 4 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start22 Oct 2018
- Primary completion15 Mar 2019
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scalp 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 485 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Natalie Yantovskiy, Study director, Taro Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880357
- Sponsor's protocol ID
- BTCS 1614
- Status last verified
- Mar 2019
- First submitted
- 15 Mar 2019
- Last updated
- 19 Mar 2019
- 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 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-group Study Comparing Taro Product to RLD and Both Active Treatments to a Placebo Control in the Treatment of Scalp Psoriasis
- ClinicalTrials.gov ID
- NCT03880357
- Acronym / sponsor ID
- BTCS 1614
- Conditions
- Scalp Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 485 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 19 Mar 2019 (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 demonstrate the superiority of the efficacy of the test and reference products over that of the placebo control in the treatment of scalp psoriasis.
Detailed description
Multi-center, double-blind, randomized, placebo controlled, parallel-group study comparing test and reference products to a placebo control in the treatment of scalp psoriasis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test Product | Experimental | Drug: Betamethasone Scalp Suspension 0.064%;0.0005%Betamethasone Scalp Suspension 0.064%;0.0005% (Taro Pharmaceuticals Inc.) |
| Reference Product | Active comparator | Drug: Taclonex®Taclonex® (Calcipotriene Hydrate and Betamethasone Dipropionate) Topical suspension 0.005%/0.064% (LEO PHARMA) |
| Placebo | Placebo comparator | Drug: Placebo topical suspensionVehicle of the test product (Taro Pharmaceuticals Inc.) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy male or non-pregnant female aged ≥18 years
- All male subjects had to agree to use accepted methods of birth control with their partners, from the day of the first application of the study drug to 30 days after the last application of the study drug
- Willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits
- A clinical diagnosis of stable (at least 6 months) scalp psoriasis involving at least 10% of the scalp
Key exclusion criteria (3 listed)
- Female subjects who were pregnant, nursing, or planning to become pregnant during study participation
- Known hypersensitivity to calcipotriene, betamethasone dipropionate, other corticosteroids, or to any ingredients in the study drugs
- 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 |
|---|---|---|
| Betamethasone Scalp Suspension 0.064%;0.0005%Also: Taclonexapplied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks. | Drug | Test Product |
| Taclonex®Also: Calcipotriene and Betamethasone Dipropionateapplied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks. | Drug | Reference Product |
| Placebo topical suspensionAlso: Vehicleapplied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks. | Drug | Placebo |
Primary outcome
treatment success on the Physician's Global Assessment (PGA) of disease severity
Time frame: Study Week 4 (Day 28 ± 4 days)
The proportion of subjects in each treatment group with "treatment success" (defined as none or minimal, a score of 0 or 1, within the treatment area) on the PGA of disease severity
clinical success on the Physician's Global Assessment (PASI) of disease severity
Time frame: Study Week 4 (Day 28 ± 4 days)
The proportion of subjects in each treatment group with "clinical success" (defined as clear or almost clear, a score of 0 or 1, at the target lesion site) on the PASI. Each psoriatic sign of scaling, erythema and plaque elevation should have a score of 0 or 1 for the subject to be considered a clinical success. The target lesion is to be identified at Baseline as the most severe lesion.
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 19 Mar 2019.
Related trials for Scalp Psoriasis
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Plaque Psoriasis
RecruitingPhase 4
Immune Spatial Features of Guselkumab Cutaneous Response
Psoriasis of Scalp
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Plaque Psoriasis, Psoriatic Arthritis
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.
Natalie Yantovskiy study director
Taro Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Betamethasone Scalp Suspension 0.064%;0.0005% and Taclonex® in people with Scalp 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 3 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 19 Mar 2019. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
treatment success on the Physician's Global Assessment (PGA) of disease severity (time frame: Study Week 4 (Day 28 ± 4 days)). The study lists 2 primary outcomes in all. 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 19 Mar 2019.