Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06024499). StuddyBuddy aggregates publicly available trial information.