A Study to Evaluate the Efficacy and Safety of HAT01H in Atopic Dermatitis

• Status: Completed
• Trial end date: 2017-07-31
• Target enrollment: 0
• Participant gender: All

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. 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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Haus Bioceuticals

Criteria

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.