A Study to Evaluate the Efficacy and Safety of HAT01H in Atopic Dermatitis
Condition: Atopic Dermatitis; Eczema
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

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.
    

Intervention name(s): HAT01H Cream; Vehicle Cream
Intervention type(s): Drug; Drug
Intervention description(s): 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 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.
Other intervention name(s): HAT01H; Vehicle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Topical Cream; Novel