Atopic Dermatitis
Conditions
Brief summary
A multi-center, open, long-term follow-up study to evaluate the efficacy and safety of FURESTEM-AD inj. in patients with moderate to severe chronic atopic dermatitis: 5-year results from the K0102 extension study
Interventions
Not applicable(observational study)
Sponsors
Kang Stem Biotech Co., Ltd.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject who enrolled K0102 Clinical Trial(parent study). 2. Subjects who understand and voluntarily sign an informed consent form
Exclusion criteria
1. In case follow-up is not possible from end of K0102 clinical trial to end of this study period 2. Any other condition which the investigator judges would make patient unsuitable for study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Assessment (Rate of Adverse Event, Number of Participants with Adverse Event) | 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 75% at Week 12 (EASI-75) | 3 years | — |
| Rate of change in EASI from baseline | 3 years | — |
| Change in EASI from baseline | 3 years | EASI range is from 0 (clear) to 72 (severe) |
| Percentage of subjects whose Investigator's Global Assessment (IGA) score at each visit is 0 or 1 | 3 years | — |
| Percentage of subjects whose IGA at each visit is 0 or 1, or improved to 2 or higher | 3 years | — |
| Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 50% at Week 12 (EASI-50) | 3 years | — |
| Rate of change in SCORAD index from baseline at each visit | 3 years | — |
| Change in SCORAD index from baseline at each visit | 3 years | SCORAD index range is from 0 (clear) to 103 (severe) |
| Rate of change in Body Surface Area(BSA) of the lesion from baseline | 3 years | — |
| Change in Body Surface Area(BSA) of the lesion from baseline | 3 years | BSA range is from 0 (clear) to 100 (severe) |
| Change in total serum Immunoglobulin E(IgE) from baseline | 3 years | — |
| Percentage of subjects whose SCORing Atopic Dermatitis (SCORAD) INDEX was decreased from baseline by more than 50% at each visit (SCORAD-50) | 3 years | — |
Countries
South Korea
Outcome results
None listed