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Completed
NCT06024499
Phase 2 Trial of HY209gel in Atopic Dermatitis Patients
Conditions: Atopic Dermatitis, Atopic Dermatitis Eczema, Atopic Dermatitis of Scalp
Sex: All
Ages: 18 Years – 100 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 210
Sponsor: Shaperon
Location: Cahaba Dermatology Skin Health Center Birmingham Alabama
Summary
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.
Eligibility Criteria
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 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
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 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
Source: ClinicalTrials.gov (NCT06024499). StuddyBuddy aggregates publicly available trial information.