Atopic Dermatitis
Conditions
Brief summary
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
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 K0104 Clinical Trial(parent study). 2. Subjects who understand and voluntarily sign an informed consent form
Exclusion criteria
1. Subjects who are expected to be unable to perform at least one follow-up during this study (K0104-E) 2. Subjects who has received/administered clinical trial drugs or medical devices by participating in other clinical trials until the first visit of this trial (K0104-E) after the completion of K0104 clinical trial 3. Subjects who are judged to be unsuitable for other researchers to participate in the research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Assessment (Rate of Adverse Event, Number of Participants with Adverse Event) | for 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 each visit (EASI-75) | for 5 years | — |
| Rate of change and Change in EASI from baseline | for 5 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 | for 5 years | — |
| Percentage of subjects whose IGA at each visit is 0 or 1, or improved to 2 or higher | 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) | for 5 years | — |
| Percentage of subjects whose EASI decreased by 50% or more at each evaluation visit compared to the baseline (EASI-50) | for 5 years | — |
| Change and rate of change in Body Surface Area (BSA) | for 5 years | — |
| Change and rate of change in total serum Immunoglobulin E (IgE) | for 5 years | — |
| Change and rate of change DLQI | for 5 years | — |
| Change and rate of change POEM | for 5 years | — |
| Change and rate of change Peak Pruritus NRS | for 5 years | — |
| Rate of change and Change in SCORAD index from baseline at each visit | for 5 years | SCORAD index range is from 0 (clear) to 103 (severe) |
Countries
South Korea
Contacts
Primary ContactEundoek Yeo
Backup ContactSeulbi Lee
Outcome results
None listed