Last updated: April 24, 2024
Sponsor: Shaperon
Overall Status: Active - Recruiting
Phase
2
Condition
Skin Infections/disorders
Eczema (Atopic Dermatitis - Pediatric)
Eczema (Atopic Dermatitis)
Treatment
HY209GEL Active
Placebo
Clinical Study ID
NCT06024499
HY209-AD-02
Ages 18-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key 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 beenclinically stable for ≥ 1 month
- Subjects with a clinical diagnosis of AD according to the Hanifin and Rajka Criteriaby 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 andbaseline visit
- Subjects should be a literate person who can read the participant information sheetand consent form/questionnaire and understand the language of the participation
Exclusion
Key Exclusion Criteria:
- Subjects who have unstable AD (i.e., remaining clinical stable less than 6 months) orany consistent requirement for any potency topical corticosteroids
- Subjects who have topical treatment with corticosteroids within 2 weeks prior tobaseline 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 otherimmunosuppressive treatments within 4 weeks prior to baseline visit
- Subjects who had dupilumab or any other biologics within 6 months prior to baselinevisit
- Subjects who take any systemic anti-infective or antibiotic treatments within 1 weekprior to baseline visit
- Subjects who had ultraviolet irradiation (including photopheresis) within 4 weeksprior to screening
- Subjects who have active malignancy or history of cancer in 5 years prior toscreening, except for treated cautions basal cell carcinoma and in situ cervicalcancer
- Subjects who have any other skin diseases that would affect the ability to assess theAD
- Subjects who are taking strong CYP3A4 inhibitor or any other concomitant drug that, inthe opinion of the PI, may cause interference with the treatment
- Subjects who participated in another drug or device trial within 4 weeks prior toscreening...etc
Study Design
Total Participants: 210
Treatment Group(s): 2
Primary Treatment: HY209GEL Active
Phase: 2
Study Start date:
March 01, 2024
Estimated Completion Date:
March 31, 2026
Study Description
Connect with a study center
Cahaba Dermatology Skin Health Center
Birmingham, Alabama 35244
United StatesActive - Recruiting
RAOOF MD Dermatology
Encino, California 16133
United StatesActive - Recruiting
Continental Clinical Solutions, LLC
Towson, Maryland 21204
United StatesActive - Recruiting
Sadick Dermatology
New York, New York 10075
United StatesActive - Recruiting
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