- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03059693
Efficacy and Tolerability of HAT1 in Patients With Moderate to Severe Atopic Dermatitis
February 16, 2017 updated by: Haus Bioceuticals
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 2
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Moderate to severe atopic dermatitis as determined by Physician's Global Assessment (PGA > 3)
- Males and females, age 12 - 65 years old inclusive
Exclusion Criteria:
- 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)
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HAT1 topical cream
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.
|
Other Names:
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Placebo Comparator: Vehicle cream
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.
|
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Scoring of Atopic Dermatitis (SCORAD) score
Time Frame: Baseline to week 12
|
Baseline to week 12
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Absolute change in Eczema Area and Severity Index (EASI) score
Time Frame: Baseline to week 12
|
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
|
Baseline to week 12
|
Incidence of treatment emergent AE's
Time Frame: Baseline to week 12
|
Baseline to week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 29, 2016
Primary Completion (Actual)
June 13, 2016
Study Completion (Actual)
July 24, 2016
Study Registration Dates
First Submitted
February 16, 2017
First Submitted That Met QC Criteria
February 16, 2017
First Posted (Actual)
February 23, 2017
Study Record Updates
Last Update Posted (Actual)
February 23, 2017
Last Update Submitted That Met QC Criteria
February 16, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HCTP16MD01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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