drugset / Trial / NCT03059693

Efficacy and Tolerability of HAT1 in Patients With Moderate to Severe Atopic Dermatitis

NCT03059693

Phase 1/2 Completed 48 enrolled Haus Bioceuticals
RandomizedParallel-groupQuadruple-blindTreatment

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. 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.

Timeline

Start
2016-02-29
Primary completion
2016-06-13
Completion
2016-07-24

Drugs

EvaluationDrugModalityDoseRoute
Subject HAT1 Unknown Topical

Indications