Evalution the Safety and Efficacy in Atopic Dermatitis Patients

Kang Stem Biotech Co., Ltd.98 enrolled

Overview

A multi-center, open, long-term follow-up study to evaluate the efficacy and safety of FURESTEM-AD inj. in patients with moderate to severe chronic atopic dermatitis: 5-year results from the K0102 extension study

Study Type

OBSERVATIONAL

Enrollment

Conditions

Atopic Dermatitis

Interventions

Not applicable(observational study)OTHER

Not applicable(observational study)

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subject who enrolled K0102 Clinical Trial(parent study). 2. Subjects who understand and voluntarily sign an informed consent form Exclusion Criteria: 1. In case follow-up is not possible from end of K0102 clinical trial to end of this study period 2. Any other condition which the investigator judges would make patient unsuitable for study participation

Locations (1)

The Catholic University of Korea, Seoul ST. Mary's Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Safety Assessment (Rate of Adverse Event, Number of Participants with Adverse Event)

Time frame: 5 years

Secondary Outcomes

Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 50% at Week 12 (EASI-50)

Time frame: 3 years

Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 75% at Week 12 (EASI-75)

Time frame: 3 years

Rate of change in EASI from baseline

Time frame: 3 years

Change in EASI from baseline

EASI range is from 0 (clear) to 72 (severe)

Time frame: 3 years

Percentage of subjects whose Investigator's Global Assessment (IGA) score at each visit is 0 or 1

Time frame: 3 years

Percentage of subjects whose IGA at each visit is 0 or 1, or improved to 2 or higher

Time frame: 3 years

Percentage of subjects whose SCORing Atopic Dermatitis (SCORAD) INDEX was decreased from baseline by more than 50% at each visit (SCORAD-50)

Time frame: 3 years

Rate of change in SCORAD index from baseline at each visit

Time frame: 3 years

Change in SCORAD index from baseline at each visit

SCORAD index range is from 0 (clear) to 103 (severe)

Data from ClinicalTrials.gov

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