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 * 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 4%, and 3 placebo) Part 2 (3 treatment groups): Total 177 subjects * Low dose of HY209gel: 59 subjects * High dose of HY209gel: 59 subjects * Placebo (Vehicle): 59 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
210
Selected two among four doses (HY209GEL 0.5% or 1% or 2% or 4%) in PART1
Placebo
Cahaba Dermatology Skin Health Center
Birmingham, Alabama, United States
RAOOF MD Dermatology
Encino, California, United States
L.A. Universal Research Center, Inc.
Los Angeles, California, United States
Percentage change in Eczema Area and Severity Index (EASI) score
To achieve lower score means disease improvement .
Time frame: at Week 8
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Zenith Research Inc.
Los Angeles, California, United States
Continental Clinical Solutions, LLC
Towson, Maryland, United States
Revival Research Institute, LLC
Southfield, Michigan, United States
Sadick Dermatology
New York, New York, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Gachon University Gil Medical Center
Seoul, South Korea
Seoul National University Bundang Hospital
Seoul, South Korea
...and 2 more locations