Administration for Placebo Group and Evalution the Safety and Efficacy in Atopic Dermatitis Patients

Kang Stem Biotech Co., Ltd.99 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Atopic Dermatitis

Interventions

Not applicable(observational study)OTHER

Not applicable(observational study)

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

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

Seoul, South Korea

RECRUITING

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 75% at each visit (EASI-75)

Time frame: 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)

Time frame: 3 years

Rate of change in EASI from baseline

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

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

IGA score is from 0 (clear) to 5 (severe)

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

Central Contacts

Seulbi Lee

CONTACT

+82-2-888-1592 sblee@kangstem.com

Jeong-hyang Woo

CONTACT

+82-2-888-1592 jhwoo@kangstem.com

Data from ClinicalTrials.gov

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