Atopic DermatitisPhase 1/2NCT03089229
A Study to Evaluate the Efficacy and Safety of HAT01H in Atopic Dermatitis
A Phase 1/2 study testing HAT01H Cream in people with Atopic Dermatitis and Eczema, run by Haus Bioceuticals at 1 site in India.
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
- Atopic Dermatitis, Eczema
- What is being tested?
- HAT01H Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 26 Mar 2017to 31 Jul 2017
- 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 PGA ≥ 3 and SCORAD > 25
- 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 3 months.
- 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 clear visual 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).
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Efficacy and Safety of HAT01H, 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. 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 novel topical treatment for eczema/atopic dermatitis (AD) denoted HAT01H, and have demonstrated that HAT01H 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 test the efficacy and safety of topical HAT01H in patients with moderate to severe atopic dermatitis.
Read the detailed description
This study is a 13 week (91 days) randomized, double-blind, in home use study among 30 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 age and disease severity of AD. The study will consist of a 1 week washout period and 12 week treatment 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
- Atopic Dermatitis, Eczema
- Being tested
- HAT01H Cream, Vehicle Cream
- Keywords
- Topical Cream, Novel
- 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.
HAT01H CreamDrug
Also called HAT01H
HAT01H Cream will be applied twice daily. 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.
Vehicle CreamDrug
Also called Vehicle
Vehicle Cream will be applied twice daily. 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 |
|---|---|---|
| HAT01H cream | Experimental | HAT01H medicated cream will come in a blinded tube. This topical medicated cream will be applied once in the morning and once in the evening at least 8 hours apart to all lesions. Treatment will continue daily until next visit. Receives: Drug: HAT01H Cream |
| Vehicle cream | Placebo comparator | Vehicle cream will come in a blinded tube. This topical medicated vehicle will be applied once in the morning and once in the evening at least 8 hours apart to all lesions. Treatment will continue 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
The primary efficacy is determined by absolute change from baseline to week 12 in inflammatory SCORAD.
Measured: Baseline to week 12
Secondary outcomes (2)
Proportion of patients achieving a Physician's Global Assessment (PGA) score of 0 or 1
The secondary efficacy measures is determined by absolute change from baseline to week 12 in PGA
Measured: Baseline to week 12
Incidence of treatment emergent Adverse Event
The secondary efficacy measures also include safety and tolerability (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 posted24 Mar 2017
- Study start26 Mar 2017
- Primary completion30 Jun 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haus Bioceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mukta Sachdev, MD, Principal investigator, Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089229
- Sponsor's protocol ID
- HCTP17MD11
- Status last verified
- Nov 2018
- First submitted
- 20 Mar 2017
- Last updated
- 7 Nov 2018
- 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 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Efficacy and Safety of HAT01H, a Novel Topical Therapeutic: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial in Patients With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03089229
- Acronym / sponsor ID
- HCTP17MD11
- Conditions
- Atopic Dermatitis, Eczema
- Keywords
- Topical Cream, Novel
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Haus BioceuticalsIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 24 Mar 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. 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 novel topical treatment for eczema/atopic dermatitis (AD) denoted HAT01H, and have demonstrated that HAT01H 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 test the efficacy and safety of topical HAT01H in patients with moderate to severe atopic dermatitis.
Detailed description
This study is a 13 week (91 days) randomized, double-blind, in home use study among 30 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 age and disease severity of AD. The study will consist of a 1 week washout period and 12 week treatment 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 |
|---|---|---|
| HAT01H cream | Experimental | Drug: HAT01H CreamHAT01H medicated cream will come in a blinded tube. This topical medicated cream will be applied once in the morning and once in the evening at least 8 hours apart to all lesions. Treatment will continue daily until next visit. |
| Vehicle cream | Placebo comparator | Drug: Vehicle CreamVehicle cream will come in a blinded tube. This topical medicated vehicle will be applied once in the morning and once in the evening at least 8 hours apart to all lesions. Treatment will continue 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 PGA ≥ 3 and SCORAD > 25
- Males and females, age 12 - 65 years old inclusive
Key exclusion criteria (12 listed)
- Is currently participating or has participated in another interventional clinical study at this or any other facility in the past 3 months.
- 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 |
|---|---|---|
| HAT01H CreamAlso: HAT01HHAT01H Cream will be applied twice daily. 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 | HAT01H cream |
| Vehicle CreamAlso: VehicleVehicle Cream will be applied twice daily. 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 | Vehicle cream |
Primary outcome
Change in Scoring of Atopic Dermatitis (SCORAD) score
Time frame: Baseline to week 12
The primary efficacy is determined by absolute change from baseline to week 12 in inflammatory SCORAD.
2 secondary outcomes
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 Adverse Event
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 7 Nov 2018.
- 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.
Mukta Sachdev, MD principal investigator
Clinical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HAT01H Cream in people with Atopic Dermatitis and Eczema, run by Haus Bioceuticals at 1 site in India.
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 12 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 7 Nov 2018. 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 India. 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 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 7 Nov 2018.