This is multi-center, randomized, double-blind, parallel, placebo-controlled phase III clinical trial to evaluate the efficacy and safety of FURESTEM-AD Inj. for moderate to severe chronic atopic dermatitis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
197
0.3mL of the following study drug is injected respectively into both upper arms, both thighs, and abdomen (total of 5 regions) as a single dose (total 1.5 mL). Treatment group: FURESTEM-AD® inj. 5.0 X 107 cells/1.5 mL
0.3mL of the following study drug is injected respectively into both upper arms, both thighs, and abdomen (total of 5 regions) as a single dose (total 1.5mL)
Pusan National University Hospital
Busan, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Dongguk University Medical Center
Ilsan, South Korea
Gachon University Gil Medical Center
over 50% reduction ratio of Eczema Area and Severity Index (EASI) as contrasted with baseline value (EASI-50)
Time frame: 12 week
over 75% reduction ratio of Eczema Area and Severity Index (EASI) as contrasted with baseline value (EASI-75)
Time frame: 12 week
Change and rafe of change in EASI index
Time frame: 24weeks
Proportion of patients who Investigator's Global Assessment (IGA) score 0 or 1
Time frame: 24weeks
Proportion of patients who Investigator's Global Assessment (IGA) score 0 or 1, or reduced more than 2 points
Time frame: 24weeks
over 50% reduction ratio of SCORing Atopic Dermatitis (SCORAD) INDEX as contrasted with baseline value (SCORAD-50)
Time frame: 24weeks
Change and rafe of change in SCORAD index
Time frame: 24weeks
Change and rafe of change in Body Surface Area (BSA)
Time frame: 24weeks
Change in total serum Immunoglobulin E (IgE)
Time frame: 24weeks
Change in Cytokine (TNF-a, Interleukin (IL)-4, IL-5, IL-6, IL-8, IL-13, IL-31, TARC (CCL17) and CCL 27 analysis)
Time frame: 24weeks
Total number of use and consumed amount of rescue medicine
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Incheon, South Korea
Catholic Medical Center
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Chung-Ang University Healthcare System
Seoul, South Korea
Hanyang University Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
...and 1 more locations
Time frame: 24weeks