Phase 2 Trial of HY209gel in Atopic Dermatitis Patients

Launched by SHAPERON · Aug 31, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called HY209gel for people with atopic dermatitis, which is a skin condition that causes itchy, inflamed skin. The trial is currently looking for participants who are at least 18 years old and have had a history of atopic dermatitis for at least six months. To be eligible, participants should have mild to moderate symptoms affecting a certain percentage of their skin. The trial aims to see how well this gel can help improve their skin condition compared to a placebo, which is an inactive substance used for comparison.

Participants in the trial can expect to be randomly assigned to receive either the HY209gel or a placebo. Neither the participants nor the researchers will know which treatment they are receiving, which helps ensure the results are fair and unbiased. This trial is being conducted at multiple locations and is an important step in understanding how effective this treatment may be for managing atopic dermatitis. If you or someone you know is struggling with this condition and meets the eligibility criteria, participating in this trial could be a valuable opportunity.

Gender

ALL

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 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