Phase 2 Trial of HY209gel in Atopic Dermatitis Patients
Atopic Dermatitis, Atopic Dermatitis Eczema, Atopic Dermatitis of Scalp
About this trial
This is an interventional treatment trial for Atopic Dermatitis
Eligibility Criteria
Key Inclusion Criteria: Male or female subjects aged 18 or older Subjects with a clinical diagnosis of AD according to the Hanifin and Rajka Criteria by a board certified/eligible dermatologist at least 6 months ago from screening 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 who can give written informed consent Key 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Placebo Comparator
PART 2 High-Dose
PART 2 Low-Dose
PART 2 Placebo
Active group selected for PART1 as a high-dose
Active group selected for PART1 as a Low-dose
Placebo group