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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.
Part 1 (2 cohorts): Total 33 subjects
Part 2 (3 treatment groups): Total 177 subjects
Part 1 is a dose-escalation part of HY209gel using lower doses of HY209gel (0.5% and 1%) with escalation (HY209gel 2% and 4%) to evaluate the pharmacokinetics(PK), safety, and tolerability of HY209gel treatment. Escalation to the next dose level will be decided by the Safety Monitoring Committee(SMC) that will review all available safety data of the planned dose level within the timeline specified on SMC charter after all enrolled subjects of each cohort complete 2-week treatment and determine the escalation to the next dose to be safe.
Based on the interim analysis for 4-week safety and efficacy data collected from Part 1, two doses will be selected for use in Part 2, which will enroll up to 177 subjects in 3 treatment arms (59 subjects per treatment arm) to evaluate the efficacy and safety of HY209gel, compared to placebo (vehicle) for 8-week treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PART 2 High-Dose | Active Comparator | Active group selected for PART1 as a high-dose |
|
| PART 2 Low-Dose | Active Comparator | Active group selected for PART1 as a Low-dose |
|
| PART 2 Placebo | Placebo Comparator | Placebo group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HY209GEL Active | Drug | Selected two among four doses (HY209GEL 0.5% or 1% or 2% or 4%) in PART1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in Eczema Area and Severity Index (EASI) score | To achieve lower score means disease improvement . | at Week 8 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cahaba Dermatology Skin Health Center | Birmingham | Alabama | 35244 | United States | ||
| RAOOF MD Dermatology |
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A Randomized, Double-blind, Placebo-controlled Study
| Placebo | Other | Placebo |
|
| Encino |
| California |
| 16133 |
| United States |
| L.A. Universal Research Center, Inc. | Los Angeles | California | 90057 | United States |
| Zenith Research Inc. | Los Angeles | California | 90212 | United States |
| Continental Clinical Solutions, LLC | Towson | Maryland | 21204 | United States |
| Revival Research Institute, LLC | Southfield | Michigan | 19505 | United States |
| Sadick Dermatology | New York | New York | 10075 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Gachon University Gil Medical Center | Seoul | South Korea |
| Seoul National University Bundang Hospital | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | South Korea |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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