Phase 2 Trial of HY209gel in Atopic Dermatitis Patients
This is a randomized, double-blind, placebo-controlled, multi-center, phase 2 study in patients with mild to moderate Atopic Dermatitis(AD), which consists of 2 parts.
Conditions:
🦠 Atopic Dermatitis 🦠 Atopic Dermatitis Eczema 🦠 Atopic Dermatitis of Scalp
🗓️ Study Start (Actual) 1 March 2024
🗓️ Primary Completion (Estimated) 31 October 2025
✅ Study Completion (Estimated) 31 March 2026
👥 Enrollment (Estimated) 210
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Birmingham, Alabama, United States
📍 Encino, California, United States
📍 Towson, Maryland, United States
📍 New York, New York, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Male or female subjects aged 18 or older
    • * Subjects who have a history of AD at least 6 months ago from screening and have been clinically stable for ≥ 1 month
    • * Subjects with a clinical diagnosis of AD according to the Hanifin and Rajka Criteria by a board certified/eligible dermatologist
    • * Subjects who have a minimum of 5% and a maximum of 30% of total body surface area (BSA) affected by AD at screening and baseline visits
    • * Subjects with vIGA score 2 or 3 corresponding to mild to moderate AD at screening and baseline visit
    • * Subjects should be a literate person who can read the participant information sheet and consent form/questionnaire and understand the language of the participation

    Exclusion Criteria:

    • * Subjects who have unstable AD (i.e., remaining clinical stable less than 6 months) or any consistent requirement for any potency topical corticosteroids
    • * Subjects who have topical treatment with corticosteroids within 2 weeks prior to baseline visit or other topical treatments of the AD area at screening (moisturizers/emollients are allowed)
    • * Subjects who had systemic treatment with corticosteroids or cyclosporine or other immunosuppressive treatments within 4 weeks prior to baseline visit
    • * Subjects who had dupilumab or any other biologics within 6 months prior to baseline visit
    • * Subjects who take any systemic anti-infective or antibiotic treatments within 1 week prior to baseline visit
    • * Subjects who had ultraviolet irradiation (including photopheresis) within 4 weeks prior to screening
    • * Subjects who have active malignancy or history of cancer in 5 years prior to screening, except for treated cautions basal cell carcinoma and in situ cervical cancer
    • * Subjects who have any other skin diseases that would affect the ability to assess the AD
    • * Subjects who are taking strong CYP3A4 inhibitor or any other concomitant drug that, in the opinion of the PI, may cause interference with the treatment
    • * Subjects who participated in another drug or device trial within 4 weeks prior to screening...etc
Ages Eligible for Study: 18 Years to 100 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 24 July 2023
  • First Submitted that Met QC Criteria 31 August 2023
  • First Posted 6 September 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 24 April 2024
  • Last Update Posted 26 April 2024
  • Last Verified July 2023