NCT03089229

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Haus Bioceuticals · Industry
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atopic Dermatitis
• Eczema

Interventions

Type	Name	Description
DRUG	HAT01H Cream	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.
DRUG	Vehicle Cream	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.

Timeline

• Start date: 2017-03-26
• Primary completion: 2017-06-30
• Completion: 2017-07-31
• First posted: 2017-03-24
• Last updated: 2018-11-07

Locations

1 site across 1 country: India