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

NCT03059693 | Completed Phase 1 DMC

• 1 other identifier: HCTP16MD01
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Dermatitis, Atopic

Keywords

Eczema; Topical

Outcome Measures

Primary Outcomes (1)

• Change in Scoring of Atopic Dermatitis (SCORAD) score

  Baseline to week 12

Secondary Outcomes (3)

• Absolute change in Eczema Area and Severity Index (EASI) score

  Baseline to week 12

• Proportion of patients achieving a Physician's Global Assessment (PGA) score of 0 or 1

  Baseline to week 12

• Incidence of treatment emergent AE's

  Baseline to week 12

Study Arms (2)

HAT1 topical cream

EXPERIMENTAL

HAT1 medicated cream will come in a blinded tube. The research team will provide instructions for the correct application of the treatment. The medicated cream will be applied twice daily (morning and evening) at least 4 hours apart to all lesions. Treatment will continue daily until next visit. If a lesion disappears, patients will continue applying the cream twice daily to the area.

Drug: HAT1 topical cream

Vehicle cream

PLACEBO COMPARATOR

Vehicle cream will come in a blinded tube. The research team will provide instructions for the correct application of the treatment. The vehicle cream will be applied twice daily (morning and evening) at least 4 hours apart to all lesions. This will be continued daily until next visit.

Drug: Vehicle cream

Interventions

HAT1 topical cream DRUG

Also known as: HAT1

HAT1 topical cream

Vehicle cream DRUG

Also known as: Placebo

Vehicle cream

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate to severe atopic dermatitis as determined by Physician's Global Assessment (PGA \> 3)
• Males and females, age 12 - 65 years old inclusive

You may not qualify if:

• Is currently participating or has participated in another interventional clinical study at this or any other facility in the past 2 weeks.
• 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 the clear visual or instrumental 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).
• Has a history of keloid formation following skin injury.
• Is routinely taking anti-coagulant medications (i.e. Plavix, Coumadin, warfarin, heparin, etc.)
• 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.

Sponsors & Collaborators

• Haus Bioceuticals: lead

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Sponsor will send all washout and test products in compliance with current Good Manufacturing Practices directly to the clinical facility prior to the start of the study. Study procedures will be in place to ensure double-blind administration of study treatments. Access to the randomization code will be strictly controlled. The quantity of all study material shipped to the clinical facility will be documented on the shipping and receiving form included within the shipment. Due to the objectives of the study, the identity of test and control treatments will not be known to investigators, care provider, outcomes assessor, research staff, or patients. Packaging and labeling of test and control treatments will be identical to maintain the blind. Products will be identified with the codes generated by the randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: February 23, 2017
• Study Start: February 29, 2016
• Primary Completion: June 13, 2016
• Study Completion: July 24, 2016
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share