PsoriasisPhase 2NCT03848806
Efficacy and Safety of HAT1 Compared to Calcipotriol in Patients With Mild to Moderate Chronic Plaque Psoriasis
A Phase 2 study testing HAT1 and Calcipotriol in people with Psoriasis, run by Haus Bioceuticals.
Trial summary
Psoriasis, the most prevalent autoimmune disease in the U.S., manifests with plaque type psoriasis vulgaris with lesions localized to the scalp, postauricular region, face, diaper area, elbows, and knees. Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- HAT1 and Calcipotriol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- No sites listed yet
- Study dates
- 29 Feb 2016to 5 Sep 2016
- Phase
- Phase 2
- 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 12 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinical diagnosis of active plaque psoriasis with a minimum PGA score of 2 but not greater than 4
- Males or Females between 12-60 years
- Treatment area amenable to topical treatment
- Attending a hospital outpatient clinic or the private practice of a dermatologist
- Following verbal and written information about the trial, the patient must provide signed and dated informed consent before any study related activity is carried out, including activities relating to washout period.
Who cannot join
- Currently have non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis or a drug induced form of psoriasis.
- Systemic treatment with immunosuppressive drugs or corticosteroids within 4 weeks prior to enrollment. (Inhaled or intranasal steroids for asthma or rhinitis may be used)
- Topical treatment with immunomodulators or corticosteroids within 4 weeks prior to enrollment.
- Phototherapy treatment within 4 weeks prior to enrollment.
- Other topical therapy on the treatment area within 1 week prior to enrollment.
- Use of anti-histamine treatment during the study
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- Clinical infection on the treatment area.
- Patients with history of cancer including skin cancer.
- Patients with history of an immunocompromised disease.
- Current participation in any other interventional clinical trial.
- Pregnancy or risk of pregnancy, and/or lactation
- History of allergy of any herbal components in HAT1
- Subjects with intense sun exposure during the study
- Patients known or suspected of not being able to comply with a trial protocol (e.g. alcoholism, drug dependency, or psychotic state)
About this study
Official title: A Phase II Multicenter Randomized Double-blind Comparator-Controlled Trial of HAT1 Compared to Calcipotriol in Patients With Mild to Moderate Chronic Plaque Psoriasis
Psoriasis, the most prevalent autoimmune disease in the U.S., manifests with plaque type psoriasis vulgaris with lesions localized to the scalp, postauricular region, face, diaper area, elbows, and knees. Inadequately controlled disease is common and a significant cause of extensive psychological and clinical morbidity in children. In addition, the safety and tolerability issues of common treatments for psoriasis including topical corticosteroids, calcipotriol, oral cytotoxic drugs, and biologic agents are especially problematic in patients that limit their use. Identification of therapies with high efficacy and safety profiles suitable for patients with psoriasis is therefore an area of critical unmet need. Haus Bioceuticals has developed a topical treatment for psoriasis denoted HAT1 (based on ingredients that have established clinical benefit), and have demonstrated that HAT1 is safe and profoundly effective in the treatment of psoriasis. This study is aimed to further evaluate the efficacy and safety of HAT1 compared to commonly used calcipotriol in patients with mild to moderate chronic plaque psoriasis.
Read the detailed description
This is a randomized, double-blind trial. All patients who meet entry criteria will be randomized to receive either topical HAT01 or calcipotriol to be applied to the affected area 2 times per day. Treatment will continue for a maximum of 12 weeks. During all study visits, patients will be evaluated for efficacy and safety. The study will comprise of a 1 week washout period. During the washout period, patients will be asked to avoid using any products on their body including topical corticosteroids, ointments, creams, etc. During the treatment phase, patients will be provided one of the two test products to use twice daily on all lesional areas. No additional ointments or creams will be allowed throughout the duration of the study. Measurements and assessments will be taken according to the schedule. Patients will be followed through 12 weeks till the end of treatment.
- Conditions
- Psoriasis
- Being tested
- HAT1, Calcipotriol
- Keywords
- Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAT1Drug
During the treatment phase, patients will be ask to apply the product twice daily on all lesional areas. The research team will provide instructions for the correct application of the treatment. If a lesion disappears, patients will continue applying the cream twice daily to the area. No additional creams, lotions or soaps other than provided test products will be allowed throughout the duration of the study.
CalcipotriolDrug
Also called Calcipotriol 0.005%
During the treatment phase, patients will be ask to apply the product twice daily on all lesional areas. The research team will provide instructions for the correct application of the treatment. If a lesion disappears, patients will continue applying the cream twice daily to the area. No additional creams, lotions or soaps other than provided test products will be allowed throughout the duration of the study.
| Study group | Role | What they receive |
|---|---|---|
| HAT1 topical | Experimental | HAT1 topical cream will come in a blinded bottle. Patients, investigators, and the trial sponsor will be unaware of the trial group assignments. Packaging and labeling of the test and comparator products will be identical to maintain the blind. Receives: Drug: HAT1 |
| Calcipotriol | Active comparator | Calcipotriol topical cream will come in a blinded bottle. Patients, investigators, and the trial sponsor will be unaware of the trial group assignments. Packaging and labeling of the test and comparator products will be identical to maintain the blind. Receives: Drug: Calcipotriol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who achieve a Psoriasis Area and Severity Index (PASI) 75 response
75% or greater reduction from baseline in the PASI score
Measured: Time Frame: Baseline to week 12
Secondary outcomes (3)
Percentage of patients who achieve a Psoriasis Area and Severity Index (PASI) 50 response
50% or greater reduction from baseline in the PASI score
Measured: Time Frame: Baseline to week 12
Percentage of patients achieving a Physicians Global Assessment (PGA) of Clear or Minimal at Week 12
Reduction of PGA score from baseline to 0 (clear) or 1 (minimal disease)
Measured: Time Frame: Baseline to week 12
Incidence of treatment emergent adverse events
Each patient were assessed for treatment emergent adverse events as part of safety assessments.
Measured: Time Frame: Baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start29 Feb 2016
- Primary completion11 Jul 2016
- Study completion5 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haus Bioceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03848806
- Sponsor's protocol ID
- HCTP15MDZ1
- Status last verified
- Feb 2019
- First submitted
- 19 Feb 2019
- Last updated
- 21 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Multicenter Randomized Double-blind Comparator-Controlled Trial of HAT1 Compared to Calcipotriol in Patients With Mild to Moderate Chronic Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT03848806
- Acronym / sponsor ID
- HCTP15MDZ1
- Conditions
- Psoriasis
- Keywords
- Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Haus BioceuticalsIndustry (pharma, biotech, devices)
- Study start
- 29 Feb 2016 (actual)
- Primary completion
- 11 Jul 2016 (actual)
- Study completion
- 5 Sep 2016 (actual)
- First posted
- 21 Feb 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.
Psoriasis, the most prevalent autoimmune disease in the U.S., manifests with plaque type psoriasis vulgaris with lesions localized to the scalp, postauricular region, face, diaper area, elbows, and knees. Inadequately controlled disease is common and a significant cause of extensive psychological and clinical morbidity in children. In addition, the safety and tolerability issues of common treatments for psoriasis including topical corticosteroids, calcipotriol, oral cytotoxic drugs, and biologic agents are especially problematic in patients that limit their use. Identification of therapies with high efficacy and safety profiles suitable for patients with psoriasis is therefore an area of critical unmet need. Haus Bioceuticals has developed a topical treatment for psoriasis denoted HAT1 (based on ingredients that have established clinical benefit), and have demonstrated that HAT1 is safe and profoundly effective in the treatment of psoriasis. This study is aimed to further evaluate the efficacy and safety of HAT1 compared to commonly used calcipotriol in patients with mild to moderate chronic plaque psoriasis.
Detailed description
This is a randomized, double-blind trial. All patients who meet entry criteria will be randomized to receive either topical HAT01 or calcipotriol to be applied to the affected area 2 times per day. Treatment will continue for a maximum of 12 weeks. During all study visits, patients will be evaluated for efficacy and safety. The study will comprise of a 1 week washout period. During the washout period, patients will be asked to avoid using any products on their body including topical corticosteroids, ointments, creams, etc. During the treatment phase, patients will be provided one of the two test products to use twice daily on all lesional areas. No additional ointments or creams will be allowed throughout the duration of the study. Measurements and assessments will be taken according to the schedule. Patients will be followed through 12 weeks till the end of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HAT1 topical | Experimental | Drug: HAT1HAT1 topical cream will come in a blinded bottle. Patients, investigators, and the trial sponsor will be unaware of the trial group assignments. Packaging and labeling of the test and comparator products will be identical to maintain the blind. |
| Calcipotriol | Active comparator | Drug: CalcipotriolCalcipotriol topical cream will come in a blinded bottle. Patients, investigators, and the trial sponsor will be unaware of the trial group assignments. Packaging and labeling of the test and comparator products will be identical to maintain the blind. |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of active plaque psoriasis with a minimum PGA score of 2 but not greater than 4
- Males or Females between 12-60 years
- Treatment area amenable to topical treatment
- Attending a hospital outpatient clinic or the private practice of a dermatologist
- Following verbal and written information about the trial, the patient must provide signed and dated informed consent before any study related activity is carried out, including activities relating to washout period.
Key exclusion criteria (14 listed)
- Currently have non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis or a drug induced form of psoriasis.
- Systemic treatment with immunosuppressive drugs or corticosteroids within 4 weeks prior to enrollment. (Inhaled or intranasal steroids for asthma or rhinitis may be used)
- Topical treatment with immunomodulators or corticosteroids within 4 weeks prior to enrollment.
- Phototherapy treatment within 4 weeks prior to enrollment.
- Other topical therapy on the treatment area within 1 week prior to enrollment.
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 |
|---|---|---|
| HAT1During the treatment phase, patients will be ask to apply the product twice daily on all lesional areas. The research team will provide instructions for the correct application of the treatment. If a lesion disappears, patients will continue applying the cream twice daily to the area. No additional creams, lotions or soaps other than provided test products will be allowed throughout the duration of the study. | Drug | HAT1 topical |
| CalcipotriolAlso: Calcipotriol 0.005%During the treatment phase, patients will be ask to apply the product twice daily on all lesional areas. The research team will provide instructions for the correct application of the treatment. If a lesion disappears, patients will continue applying the cream twice daily to the area. No additional creams, lotions or soaps other than provided test products will be allowed throughout the duration of the study. | Drug | Calcipotriol |
Primary outcome
Percentage of patients who achieve a Psoriasis Area and Severity Index (PASI) 75 response
Time frame: Time Frame: Baseline to week 12
75% or greater reduction from baseline in the PASI score
3 secondary outcomes
Percentage of patients who achieve a Psoriasis Area and Severity Index (PASI) 50 response
Time frame: Time Frame: Baseline to week 12
Percentage of patients achieving a Physicians Global Assessment (PGA) of Clear or Minimal at Week 12
Time frame: Time Frame: Baseline to week 12
Incidence of treatment emergent adverse events
Time frame: Time Frame: Baseline to week 12
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 21 Feb 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HAT1 and Calcipotriol in people with Psoriasis, run by Haus Bioceuticals.
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 5 inclusion and 14 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 21 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Percentage of patients who achieve a Psoriasis Area and Severity Index (PASI) 75 response (time frame: Time Frame: Baseline to week 12). 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 21 Feb 2019.