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

NCT03089229 | Completed Phase 1 DMC

• 1 other identifier: HCTP17MD11
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis; Eczema

Keywords

Topical Cream; Novel

Outcome Measures

Primary Outcomes (1)

• Change in Scoring of Atopic Dermatitis (SCORAD) score

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

  Baseline to week 12

Secondary Outcomes (2)

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

  Baseline to week 12

• Incidence of treatment emergent Adverse Event

  Baseline to week 12

Study Arms (2)

HAT01H cream

EXPERIMENTAL

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.

Drug: HAT01H Cream

Vehicle cream

PLACEBO COMPARATOR

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.

Drug: Vehicle Cream

Interventions

HAT01H Cream DRUG

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.

Also known as: HAT01H

HAT01H cream

Vehicle Cream DRUG

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.

Also known as: Vehicle

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 PGA ≥ 3 and SCORAD \> 25
• 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 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.

Sponsors & Collaborators

• Haus Bioceuticals: lead

Study Sites (1)

Clinical Research Pvt Ltd

Bangalore, Karnataka, India

Location

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 Officials

• Mukta Sachdev, MD

  Clinical

  PRINCIPAL INVESTIGATOR

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: March 20, 2017
• First Posted: March 24, 2017
• Study Start: March 26, 2017
• Primary Completion: June 30, 2017
• Study Completion: July 31, 2017
• Last Updated: November 7, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share

Locations

IN (1)