This clinical trial study is two-stage, multi-center, randomized, double-blind, placebo controlled, phase 3 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
308
the following study drug is injected respectively into both upper arms, both thighs, and abdomen (total of 5 regions)
the following study drug is injected respectively into both upper arms, both thighs, and abdomen (total of 5 regions)
Chosun University Hospital
Gwangju, Jeollanam-do, South Korea
RECRUITINGEASI(Eczema Area and Severity Index)-50
Ratio of subject whose Eczema Area and Severity Index (EASI) decreased over 50% as contrasted with baseline value
Time frame: 12 weeks
EASI(Eczema Area and Severity Index)-75
Ratio of subjects whose Eczema Area and Severity Index (EASI) decreased over 75% as contrasted with baseline value
Time frame: 2,4,8,12 weeks
EASI(Eczema Area and Severity Index)-50
Ratio of subjects whose Eczema Area and Severity Index (EASI) decreased over 50% as contrasted with baseline value
Time frame: 2,4,8 weeks
EASI(Eczema Area and Severity Index) index
Change and rate of change in Eczema Area and Severity Index (EASI) index as contrasted with baseline value
Time frame: 2,4,8,12 weeks
IGA(Investigator's Global Assessment) Score
Proportion of subjects who Investigator's Global Assessment (IGA) score 0 or 1 and at least 2 points reduction in IGA score as contrasted with baseline value
Time frame: 2,4,8,12 weeks
SCORAD(SCORing Atopic Dermatitis)-50
Ratio of subjects whose SCORing Atopic Dermatitis (SCORAD) decreased over 50% as contrasted with baseline value
Time frame: 2,4,8,12 weeks
SCORAD(SCORing Atopic Dermatitis) index
Change and rate of change in SCORing Atopic Dermatitis (SCORAD) index as contrasted with baseline value
Time frame: 2,4,8,12 weeks
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BSA(Body Surface Area)
Change and rate of change in Body Surface Area (BSA) as contrasted with baseline value
Time frame: 2,4,8,12 weeks
Worst daily Pruritus NRS(Numerical Rating Scale)
Rate of change in Worst daily Pruritus Numerical Rating Scale (NRS) as contrasted with baseline value
Time frame: 2,4,8,12 weeks
Average daily Pruritus NRS(Numerical Rating Scale)
Rate of change in Average daily Pruritus Numerical Rating Scale (NRS) as contrasted with baseline value
Time frame: 2,4,8,12 weeks
Worst daily Pruritus NRS(Numerical Rating Scale) - 4 points
Proportion of patients at least 4 points reduction in Worst daily Pruritus Numerical Rating Scale (NRS) as contrasted with baseline value
Time frame: 2,4,8,12 weeks
POEM(Patient-Oriented Eczema Measure)
Change and rate of change in Patient-Oriented Eczema Measure (POEM) as contrasted with baseline value
Time frame: 2,4,8,12 weeks
DLQI(Dermatology Life Quality Index)
Change and rate of change in Dermatology Life Quality Index (DLQI) as contrasted with baseline value
Time frame: 2,4,8,12 weeks
Rescue medicine
Total number of use and consumed amount of rescue medicine
Time frame: up to 12, 24 weeks