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

Primary Purpose

Dermatitis, Atopic

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

HAT1 topical cream

Vehicle cream

About this trial

This is an interventional treatment trial for Dermatitis, Atopic focused on measuring Eczema, Topical

Eligibility Criteria

12 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Moderate to severe atopic dermatitis as determined by Physician's Global Assessment (PGA > 3)
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 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HAT1 topical cream

Vehicle cream

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Scoring of Atopic Dermatitis (SCORAD) score

Secondary Outcome Measures

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

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

Incidence of treatment emergent AE's

Full Information

NCT ID

NCT03059693

First Posted

February 16, 2017

Last Updated

February 16, 2017

Sponsor

Haus Bioceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03059693

Brief Title

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

Official Title

Efficacy and Safety of HAT1, a Novel Topical Therapeutic: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial in Patients With Moderate to Severe Atopic Dermatitis

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

February 29, 2016 (Actual)

Primary Completion Date

June 13, 2016 (Actual)

Study Completion Date

July 24, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Haus Bioceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

This study is a 17 week (119 days) randomized, double-blind, in home use study among 48 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 disease severity, age, and body location of AD lesions (listed in order of importance). The study will consist of a 1 week washout period, 12 week treatment phase and a 4 week regression 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dermatitis, Atopic

Keywords

Eczema, Topical

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HAT1 topical cream

Arm Type

Experimental

Arm Description

Arm Title

Vehicle cream

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

HAT1 topical cream

Other Intervention Name(s)

HAT1

Intervention Type

Drug

Intervention Name(s)

Vehicle cream

Other Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Change in Scoring of Atopic Dermatitis (SCORAD) score

Time Frame

Baseline to week 12

Secondary Outcome Measure Information:

Title

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

Time Frame

Baseline to week 12

Title

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

Time Frame

Baseline to week 12

Title

Incidence of treatment emergent AE's

Time Frame

Baseline to week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Moderate to severe atopic dermatitis as determined by Physician's Global Assessment (PGA > 3) 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 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.

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

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

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