Status:
RECRUITING
Phase 2 Trial of HY209gel in Atopic Dermatitis Patients
Lead Sponsor:
Shaperon
Conditions:
Atopic Dermatitis
Atopic Dermatitis Eczema
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
Brief 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.
Detailed Description
Part 1 (2 cohorts): Total 33 subjects * Cohort A: 15 subjects (6 HY209gel 0.5%, 6 HY209gel 1%, and 3 placebo) * Cohort B: 9 subjects (6 HY209gel 2%, and 3 placebo) * Cohort C: 9 subjects (6 HY209gel ...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT06024499
Start Date
March 1 2024
End Date
March 31 2026
Last Update
April 26 2024
Active Locations (4)
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1
Cahaba Dermatology Skin Health Center
Birmingham, Alabama, United States, 35244
2
RAOOF MD Dermatology
Encino, California, United States, 16133
3
Continental Clinical Solutions, LLC
Towson, Maryland, United States, 21204
4
Sadick Dermatology
New York, New York, United States, 10075