A Study to Evaluate the Efficacy and Safety of HAT01H in Atopic Dermatitis
| Status: | Completed |
|---|---|
| Conditions: | Psoriasis, Skin and Soft Tissue Infections, Dermatology, Dermatology, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 12 - 65 |
| Updated: | 12/20/2017 |
| Start Date: | March 26, 2017 |
| End Date: | July 31, 2017 |
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.
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.
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.
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.
Inclusion Criteria:
- Moderate to severe atopic dermatitis as determined by PGA ≥ 3 and SCORAD > 25
- 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 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)
- 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.
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