A multi-center, open, long-term follow-up study to Evaluate the Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD inj. for Moderate to Severe Chronic Atopic Dermatitis: 5-year Results from the K0104 Extension Study
Study Type
OBSERVATIONAL
Enrollment
102
Not applicable(observational study)
Dongguk University Medical Center
Ilsan, South Korea
Safety Assessment (Rate of Adverse Event, Number of Participants with Adverse Event)
Time frame: for 5 years
Percentage of subjects whose EASI decreased by 50% or more at each evaluation visit compared to the baseline (EASI-50)
Time frame: for 5 years
Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 75% at each visit (EASI-75)
Time frame: for 5 years
Rate of change and Change in EASI from baseline
EASI range is from 0 (clear) to 72 (severe)
Time frame: for 5 years
Percentage of subjects whose Investigator's Global Assessment (IGA) score at each visit is 0 or 1
Time frame: for 5 years
Percentage of subjects whose IGA at each visit is 0 or 1, or improved to 2 or higher
Time frame: for 5 years
Percentage of subjects whose SCORing Atopic Dermatitis (SCORAD) INDEX was decreased from baseline by more than 50% at each visit (SCORAD-50)
Time frame: for 5 years
Rate of change and Change in SCORAD index from baseline at each visit
SCORAD index range is from 0 (clear) to 103 (severe)
Time frame: for 5 years
Change and rate of change in Body Surface Area (BSA)
Time frame: for 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Change and rate of change in total serum Immunoglobulin E (IgE)
Time frame: for 5 years
Change and rate of change DLQI
Time frame: for 5 years
Change and rate of change POEM
Time frame: for 5 years
Change and rate of change Peak Pruritus NRS
Time frame: for 5 years