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

Primary Purpose

Atopic Dermatitis, Eczema

Status

Completed

Phase

Phase 1

Locations

India

Study Type

Interventional

Intervention

HAT01H Cream

Vehicle Cream

About this trial

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

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 PGA ≥ 3 and SCORAD > 25
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 3 months.
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 clear visual 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).
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

Clinical Research Pvt Ltd

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HAT01H cream

Vehicle cream

Arm Description

HAT01H medicated cream will come in a blinded tube. This topical medicated cream will be applied once in the morning and once in the evening at least 8 hours apart to all lesions. Treatment will continue daily until next visit.

Vehicle cream will come in a blinded tube. This topical medicated vehicle will be applied once in the morning and once in the evening at least 8 hours apart to all lesions. Treatment will continue daily until next visit.

Outcomes

Primary Outcome Measures

Change in Scoring of Atopic Dermatitis (SCORAD) score

The primary efficacy is determined by absolute change from baseline to week 12 in inflammatory SCORAD.

Secondary Outcome Measures

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

The secondary efficacy measures is determined by absolute change from baseline to week 12 in PGA

Incidence of treatment emergent Adverse Event

The secondary efficacy measures also include safety and tolerability (incidence of treatment emergent AE's)

Full Information

NCT ID

NCT03089229

First Posted

March 20, 2017

Last Updated

November 5, 2018

Sponsor

Haus Bioceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03089229

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

March 26, 2017 (Actual)

Primary Completion Date

June 30, 2017 (Actual)

Study Completion Date

July 31, 2017 (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

Product Manufactured in and Exported from the U.S.

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. 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.

6. Conditions and Keywords

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

Atopic Dermatitis, Eczema

Keywords

Topical Cream, Novel

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

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HAT01H cream

Arm Type

Experimental

Arm Description

Arm Title

Vehicle cream

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

HAT01H Cream

Other Intervention Name(s)

HAT01H

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Vehicle Cream

Other Intervention Name(s)

Vehicle

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Scoring of Atopic Dermatitis (SCORAD) score

Description

The primary efficacy is determined by absolute change from baseline to week 12 in inflammatory SCORAD.

Time Frame

Baseline to week 12

Secondary Outcome Measure Information:

Title

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

Description

The secondary efficacy measures is determined by absolute change from baseline to week 12 in PGA

Time Frame

Baseline to week 12

Title

Incidence of treatment emergent Adverse Event

Description

The secondary efficacy measures also include safety and tolerability (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 PGA ≥ 3 and SCORAD > 25 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 3 months. 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 clear visual 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). 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mukta Sachdev, MD

Organizational Affiliation

Clinical

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinical Research Pvt Ltd

City

Bangalore

State/Province

Karnataka

Country

India

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

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

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