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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atopic Dermatitis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Not applicable(observational study) | Other | Not applicable(observational study) |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety Assessment (Rate of Adverse Event, Number of Participants with Adverse Event) | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 50% at each visit (EASI-50) |
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Inclusion Criteria:
Exclusion Criteria:
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Moderate to Severe Atopic Dermatitis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seulbi Lee | Contact | +82-2-888-1592 | sblee@kangstem.com | |
| Jeong-hyang Woo | Contact | +82-2-888-1592 | jhwoo@kangstem.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of Korea, Seoul ST. Mary's Hospital | Recruiting | Seoul | 06591 | South Korea |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| 3 years |
| Rate of change in EASI from baseline | EASI range is from 0 (clear) to 72 (severe) | 3 years |
| Change in EASI from baseline | EASI range is from 0 (clear) to 72 (severe) | 3 years |
| 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 | IGA score is from 0 (clear) to 5 (severe) | 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 |
| Rate of change in SCORAD index from baseline at each visit | 3 years |
| Change in SCORAD index from baseline at each visit | SCORAD index range is from 0 (clear) to 103 (severe) | 3 years |
| 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 | SCORAD index range is from 0 (clear) to 103 (severe) | 3 years |
| Change in total serum Immunoglobulin E(IgE) from baseline | 3 years |
| Rate of change in total serum Immunoglobulin E(IgE) from baseline | 3 years |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |