Phase 2 Trial of HY209gel in Atopic Dermatitis Patients

Prior treatment

• 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 are taking 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

Other illness

• 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

• 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