Dermatitis, AtopicPhase 1/2NCT03059693
Efficacy and Tolerability of HAT1 in Patients With Moderate to Severe Atopic Dermatitis
A Phase 1/2 study testing HAT1 topical cream in people with Dermatitis, Atopic, run by Haus Bioceuticals.
Trial summary
Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by a disturbance of epidermal-barrier function that results in intensely pruritic subacute and chronic eczematous plaques. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- HAT1 topical cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 29 Feb 2016to 24 Jul 2016
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Moderate to severe atopic dermatitis as determined by Physician's Global Assessment (PGA > 3)
- Males and females, age 12 - 65 years old inclusive
Who cannot join
- Is currently participating or has participated in another interventional clinical study at this or any other facility in the past 2 weeks.
- Currently or has been diagnosed or treated for cancer in the past 5 years.
- Requires any topical or systemic medications that could affect the course of their atopic dermatitis during the study period (except inhaled steroids and/or stable antihistamines for asthma or allergies).
- Has a known hypersensitivity to any corticosteroid creams.
- Has any active infections or has used antibiotics in the past 7 days.
- Has any physical attributes or skin conditions that might interfere with the clear visual or instrumental assessments.(i.e. cuts, sunburn, birth marks, tattoos, extensive scarring, excessive hair growth or acne)
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- Has an immunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS, lupus rheumatoid arthritis) which could place the subject at risk or interfere with the accuracy of the study results.
- Has used any immunosuppressant drugs or immunotherapy within the past 30 days or 5 half-lives.
- Is an employee of the sponsor company or clinical testing site.
- Is dependent on oral medication for any skin disease/condition or could not, in the opinion of the Investigator tolerate the restriction of discontinuing the medicine as required in this study.
- Is currently pregnant or lactating or planning to become pregnant in the next 6 months (using double contraception for prevention).
- Has a history of keloid formation following skin injury.
- Is routinely taking anti-coagulant medications (i.e. Plavix, Coumadin, warfarin, heparin, etc.)
- Any other condition or factor the Investigator or their duly assigned representative believes may affect the ability of the subject to complete the study or the interpretation of the results.
About this study
Official title: Efficacy and Safety of HAT1, a Novel Topical Therapeutic: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial in Patients With Moderate to Severe Atopic Dermatitis
Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by a disturbance of epidermal-barrier function that results in intensely pruritic subacute and chronic eczematous plaques. As the most common cause of chronic inflammatory skin diseases, AD is a major cause of morbidity and suffering, affecting upto 30% of children, and increasing in prevalence throughout the world. It is estimated that the direct cost of AD in the US alone ranged from $0.9 billion to $3.8 billion every year. The current therapy of AD is reactive, where the flares are treated through symptomatic management with topical corticosteroids and calcineurin inhibitors. Given that these medications have long-term side-effects, and given the chronically relapsing immunopathogenic nature of AD, there is an imperative need for safer anti-inflammatory medications. Haus Bioceuticals (Haus) has developed a topical treatment for eczema/atopic dermatitis (AD) denoted HAT1, and have demonstrated that HAT1 is safe and profoundly effective in the treatment of AD, controlling signs and symptoms in 85% of patients with AD. This study is aimed to further evaluate the potential of developing HAT1 as an integral part of AD therapy.
Read the detailed description
This study is a 17 week (119 days) randomized, double-blind, in home use study among 48 male and female subjects with moderate to severe active atopic dermatitis (AD). The study will include subjects with ages 12 - 65 years old inclusive. Group assignments will be balanced by disease severity, age, and body location of AD lesions (listed in order of importance). The study will consist of a 1 week washout period, 12 week treatment phase and a 4 week regression phase. During the treatment phase, subject will be provided one of the two test products to use twice daily on all lesions and non-lesional areas as instructed. No additional creams, lotions or soaps other than provided test products will be allowed throughout the duration of the study. Measurements, expert visual assessments and self-assessments will be taken as described below. Safety and tolerability will be evaluated by incidence of AE's (defined per CTCAE), exacerbations, application site reactions/infections, and lab evals. There will also be consumption/compliance checks and dermatological evaluations at each visit.
- Conditions
- Dermatitis, Atopic
- Being tested
- HAT1 topical cream, Vehicle cream
- Keywords
- Eczema, Topical
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAT1 topical creamDrug
Also called HAT1
Vehicle creamDrug
Also called Placebo
| Study group | Role | What they receive |
|---|---|---|
| HAT1 topical cream | Experimental | HAT1 medicated cream will come in a blinded tube. The research team will provide instructions for the correct application of the treatment. The medicated cream will be applied twice daily (morning and evening) at least 4 hours apart to all lesions. Treatment will continue daily until next visit. If a lesion disappears, patients will continue applying the cream twice daily to the area. Receives: Drug: HAT1 topical cream |
| Vehicle cream | Placebo comparator | Vehicle cream will come in a blinded tube. The research team will provide instructions for the correct application of the treatment. The vehicle cream will be applied twice daily (morning and evening) at least 4 hours apart to all lesions. This will be continued daily until next visit. Receives: Drug: Vehicle cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Scoring of Atopic Dermatitis (SCORAD) score
Measured: Baseline to week 12
Secondary outcomes (3)
Absolute change in Eczema Area and Severity Index (EASI) score
Measured: Baseline to week 12
Proportion of patients achieving a Physician's Global Assessment (PGA) score of 0 or 1
Measured: Baseline to week 12
Incidence of treatment emergent AE's
Measured: 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 posted23 Feb 2017
- Study start29 Feb 2016
- Primary completion13 Jun 2016
- Study completion24 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 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
- NCT03059693
- Sponsor's protocol ID
- HCTP16MD01
- Status last verified
- Feb 2017
- First submitted
- 16 Feb 2017
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of HAT1, a Novel Topical Therapeutic: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial in Patients With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03059693
- Acronym / sponsor ID
- HCTP16MD01
- Conditions
- Dermatitis, Atopic
- Keywords
- Eczema, Topical
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Haus BioceuticalsIndustry (pharma, biotech, devices)
- Study start
- 29 Feb 2016 (actual)
- Primary completion
- 13 Jun 2016 (actual)
- Study completion
- 24 Jul 2016 (actual)
- First posted
- 23 Feb 2017 (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.
Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by a disturbance of epidermal-barrier function that results in intensely pruritic subacute and chronic eczematous plaques. As the most common cause of chronic inflammatory skin diseases, AD is a major cause of morbidity and suffering, affecting upto 30% of children, and increasing in prevalence throughout the world. It is estimated that the direct cost of AD in the US alone ranged from $0.9 billion to $3.8 billion every year. The current therapy of AD is reactive, where the flares are treated through symptomatic management with topical corticosteroids and calcineurin inhibitors. Given that these medications have long-term side-effects, and given the chronically relapsing immunopathogenic nature of AD, there is an imperative need for safer anti-inflammatory medications. Haus Bioceuticals (Haus) has developed a topical treatment for eczema/atopic dermatitis (AD) denoted HAT1, and have demonstrated that HAT1 is safe and profoundly effective in the treatment of AD, controlling signs and symptoms in 85% of patients with AD. This study is aimed to further evaluate the potential of developing HAT1 as an integral part of AD therapy.
Detailed description
This study is a 17 week (119 days) randomized, double-blind, in home use study among 48 male and female subjects with moderate to severe active atopic dermatitis (AD). The study will include subjects with ages 12 - 65 years old inclusive. Group assignments will be balanced by disease severity, age, and body location of AD lesions (listed in order of importance). The study will consist of a 1 week washout period, 12 week treatment phase and a 4 week regression phase. During the treatment phase, subject will be provided one of the two test products to use twice daily on all lesions and non-lesional areas as instructed. No additional creams, lotions or soaps other than provided test products will be allowed throughout the duration of the study. Measurements, expert visual assessments and self-assessments will be taken as described below. Safety and tolerability will be evaluated by incidence of AE's (defined per CTCAE), exacerbations, application site reactions/infections, and lab evals. There will also be consumption/compliance checks and dermatological evaluations at each visit.
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 cream | Experimental | Drug: HAT1 topical creamHAT1 medicated cream will come in a blinded tube. The research team will provide instructions for the correct application of the treatment. The medicated cream will be applied twice daily (morning and evening) at least 4 hours apart to all lesions. Treatment will continue daily until next visit. If a lesion disappears, patients will continue applying the cream twice daily to the area. |
| Vehicle cream | Placebo comparator | Drug: Vehicle creamVehicle cream will come in a blinded tube. The research team will provide instructions for the correct application of the treatment. The vehicle cream will be applied twice daily (morning and evening) at least 4 hours apart to all lesions. This will be continued daily until next visit. |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Moderate to severe atopic dermatitis as determined by Physician's Global Assessment (PGA > 3)
- Males and females, age 12 - 65 years old inclusive
Key exclusion criteria (14 listed)
- Is currently participating or has participated in another interventional clinical study at this or any other facility in the past 2 weeks.
- Currently or has been diagnosed or treated for cancer in the past 5 years.
- Requires any topical or systemic medications that could affect the course of their atopic dermatitis during the study period (except inhaled steroids and/or stable antihistamines for asthma or allergies).
- Has a known hypersensitivity to any corticosteroid creams.
- Has any active infections or has used antibiotics in the past 7 days.
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 |
|---|---|---|
| HAT1 topical creamAlso: HAT1 | Drug | HAT1 topical cream |
| Vehicle creamAlso: Placebo | Drug | Vehicle cream |
Primary outcome
Change in Scoring of Atopic Dermatitis (SCORAD) score
Time frame: Baseline to week 12
3 secondary outcomes
Absolute change in Eczema Area and Severity Index (EASI) score
Time frame: Baseline to week 12
Proportion of patients achieving a Physician's Global Assessment (PGA) score of 0 or 1
Time frame: Baseline to week 12
Incidence of treatment emergent AE's
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 23 Feb 2017.
- Individual participant dataSharing planned: Yes
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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 1/2 study testing HAT1 topical cream in people with Dermatitis, Atopic, 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 2 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 23 Feb 2017. 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. 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 combined 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.
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?
Change in Scoring of Atopic Dermatitis (SCORAD) score (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 23 Feb 2017.