Testing HY209gel for treating Atopic Dermatitis
A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of HY209 Gel in Patients With Mild to Moderate Atopic Dermatitis(AD)
This study is testing a new gel called HY209 to see if it can safely help people with mild to moderate Atopic Dermatitis feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Shaperon Industry-sponsored |
| Drugs / interventions | dupilumab |
| Locations | 4 sites (Birmingham, Alabama and 3 other locations) |
| Trial ID | NCT06024499 on ClinicalTrials.gov |
What this trial studies
This phase 2 clinical trial evaluates the safety and efficacy of HY209gel in patients with mild to moderate Atopic Dermatitis. The study is divided into two parts: the first part involves a dose-escalation approach with different concentrations of HY209gel and a placebo to assess pharmacokinetics, safety, and tolerability. The second part will focus on the selected doses from Part 1, enrolling a larger group of subjects to compare the effects of HY209gel against a placebo over an 8-week treatment period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with a clinical diagnosis of mild to moderate Atopic Dermatitis affecting 5% to 30% of their body surface area.
Not a fit: Patients with unstable Atopic Dermatitis or those requiring corticosteroid treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from Atopic Dermatitis.
How similar studies have performed: Other studies have shown promise in using topical treatments for Atopic Dermatitis, making this approach a continuation of established research.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birmingham, Alabama and 3 other locations
- Cahaba Dermatology Skin Health Center — Birmingham, Alabama, United States (Recruiting)
- RAOOF MD Dermatology — Encino, California, United States (Recruiting)
- Continental Clinical Solutions, LLC — Towson, Maryland, United States (Recruiting)
- Sadick Dermatology — New York, New York, United States (Recruiting)
Study contacts
- Study coordinator: Shaperon Shaperon
- Email: seoh@shaperon.com
- Phone: 82-2-6083-8315
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.