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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HAT1 topical cream | Drug |
|
| |
| Vehicle cream |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Scoring of Atopic Dermatitis (SCORAD) score | Baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in Eczema Area and Severity Index (EASI) score | Baseline to week 12 | |
| Proportion of patients achieving a Physician's Global Assessment (PGA) score of 0 or 1 | Baseline to week 12 | |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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The Sponsor will send all washout and test products in compliance with current Good Manufacturing Practices directly to the clinical facility prior to the start of the study. Study procedures will be in place to ensure double-blind administration of study treatments. Access to the randomization code will be strictly controlled. The quantity of all study material shipped to the clinical facility will be documented on the shipping and receiving form included within the shipment. Due to the objectives of the study, the identity of test and control treatments will not be known to investigators, care provider, outcomes assessor, research staff, or patients. Packaging and labeling of test and control treatments will be identical to maintain the blind. Products will be identified with the codes generated by the randomization.
| Drug |
|
|
| Incidence of treatment emergent AE's |
| Baseline to week 12 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |