Atopic Dermatitis
Conditions
Brief summary
A Multi-center, Open, Single-arm Clinical Trial to Evaluate the Safety and Efficacy of FURESTEM-AD inj. in Patients with Moderate to Severe Chronic Atopic Dermatitis Who Participated in a Placebo Group in K0102 Clinical Trial: 2nd Extension Study of K0102
Interventions
Not applicable(observational study)
Sponsors
Kang Stem Biotech Co., Ltd.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Subject who enrolled K0102 Clinical Trial(parent study) and be assigned to a placebo group 2. Subjects who understand and voluntarily sign an informed consent form
Exclusion criteria
1. Subjects with medical history or surgery/procedure history 2. Subjects with diseases at the time of participation in this study (systemic infection, other serious skin disorders, pigmentation or extensive scarring in atopic dermatitis symptom region) 3. Pregnant, breast-feeding women or women who plan to become pregnant during six months after administering the clinical trial medication 4. Subjects who participate in other clinical trial or participated in other clinical trial within 4 weeks 5. In case follow-up is not possible to end of this study period 6. 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 50% at each visit (EASI-50) | 3 years | — |
| Rate of change in EASI from baseline | 3 years | EASI range is from 0 (clear) to 72 (severe) |
| 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 | IGA score is from 0 (clear) to 5 (severe) |
| Percentage of subjects whose SCORing Atopic Dermatitis (SCORAD) INDEX was decreased from baseline by more than 50% at each visit (SCORAD-50) | 3 years | — |
| Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 75% at each visit (EASI-75) | 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 Extent, Intensity of lesions and subject symptoms for SCORAD index from baseline at each visit | 3 years | — |
| Change in Extent, Intensity of lesions and subject symptoms for SCORAD index from baseline at each visit | 3 years | SCORAD index range is from 0 (clear) to 103 (severe) |
| Change in total serum Immunoglobulin E(IgE) from baseline | 3 years | — |
| Rate of change in total serum Immunoglobulin E(IgE) from baseline | 3 years | — |
| Rate of change in SCORAD index from baseline at each visit | 3 years | — |
Countries
South Korea
Contacts
Primary ContactSeulbi Lee
Backup ContactJeong-hyang Woo
Outcome results
None listed