Status:
COMPLETED
Safety and Efficacy of FURESTEM-AD Inj. in Patients With Moderate to Severe Chronic Atopic Dermatitis(AD)
Lead Sponsor:
Kang Stem Biotech Co., Ltd.
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
19+ years
Phase:
PHASE3
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 derm...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2019
Estimated Enrollment :
197 Patients enrolled
Trial Details
Trial ID
NCT03269773
Start Date
April 25 2018
End Date
June 20 2019
Last Update
September 12 2019
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Pusan National University Hospital
Busan, South Korea
2
Chonnam National University Hospital
Gwangju, South Korea
3
Dongguk University Medical Center
Ilsan, South Korea
4
Gachon University Gil Medical Center
Incheon, South Korea