Safety and Efficacy of FURESTEM-AD Inj. in Patients With Moderate to Severe Chronic Atopic Dermatitis(AD)
- Conditions
- Atopic Dermatitis
- Interventions
- Biological: FURESTEM-AD Inj.Other: Placebo
- Registration Number
- NCT03269773
- Lead Sponsor
- Kang Stem Biotech Co., Ltd.
- Brief Summary
This is multi-center, randomized, double-blind, parallel, placebo-controlled phase III clinical trial to evaluate the efficacy and safety of FURESTEM-AD Inj. for moderate to severe chronic atopic dermatitis
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 197
- Of either gender, aged >=19
- Atopic Dermatitis subjects who are coincident with Hanifin and Rajka diagnosis criteria
- Chronic Atopic Dermatitis that has been present for at least 3 years
- EASI>=12 at screening and baseline visit
- IGA>=3, SCORAD index>=25, BSA >=10% of AD involvement at screegning and baseline visit
- Subjects with documented record of inadequate response to the stable use of topical atopic dermatitis treatment within 24 weeks before participating in the study, or whom are inadvisable due to safety risks
- Subjects who understand and voluntarily sign an informed consent form
- Subjects with medical history or surgery/procedure history
- 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)
- Subjects who need prohibited medication during clinical period
- Pregnant, breast-feeding women or women who plan to become pregnant during this study
- Subjects who currently participate in other clinical trial or participated in other clinical trial within 4 weeks
- Any other condition which the investigator judges would make patient unsuitable for study participation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FURESTEM-AD Inj. FURESTEM-AD Inj. hUCB-MSC 5.0x10\^7 cells Placebo Placebo -
- Primary Outcome Measures
Name Time Method over 50% reduction ratio of Eczema Area and Severity Index (EASI) as contrasted with baseline value (EASI-50) 12 week
- Secondary Outcome Measures
Name Time Method Proportion of patients who Investigator's Global Assessment (IGA) score 0 or 1 24weeks Proportion of patients who Investigator's Global Assessment (IGA) score 0 or 1, or reduced more than 2 points 24weeks Total number of use and consumed amount of rescue medicine 24weeks Change and rafe of change in Body Surface Area (BSA) 24weeks Change in Cytokine (TNF-a, Interleukin (IL)-4, IL-5, IL-6, IL-8, IL-13, IL-31, TARC (CCL17) and CCL 27 analysis) 24weeks Change in total serum Immunoglobulin E (IgE) 24weeks Change and rafe of change in SCORAD index 24weeks over 75% reduction ratio of Eczema Area and Severity Index (EASI) as contrasted with baseline value (EASI-75) 12 week Change and rafe of change in EASI index 24weeks over 50% reduction ratio of SCORing Atopic Dermatitis (SCORAD) INDEX as contrasted with baseline value (SCORAD-50) 24weeks
Related Research Topics
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Trial Locations
- Locations (11)
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Catholic Medical Center
🇰🇷Seoul, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Dongguk University Medical Center
🇰🇷Ilsan, Korea, Republic of
Chung-Ang University Healthcare System
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Hanyang University Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of