Evalution the Safety and Efficacy in Atopic Dermatitis Patients

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03962387
• Other study ID #: K0102-E
• Status: Active, not recruiting
• Start date: April 5, 2019
• Est. completion date: January 2, 2024

Study information

• Verified date: June 2021
• Source: Kang Stem Biotech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 98
• Est. completion date: January 2, 2024
• Est. primary completion date: January 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Other:
• Not applicable(observational study)
Not applicable(observational study)

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Korea, Seoul ST. Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kang Stem Biotech Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Assessment (Rate of Adverse Event, Number of Participants with Adverse Event)		5 years
Secondary	Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 50% at Week 12 (EASI-50)		3 years
Secondary	Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 75% at Week 12 (EASI-75)		3 years
Secondary	Rate of change in EASI from baseline		3 years
Secondary	Change in EASI from baseline	EASI range is from 0 (clear) to 72 (severe)	3 years
Secondary	Percentage of subjects whose Investigator's Global Assessment (IGA) score at each visit is 0 or 1		3 years
Secondary	Percentage of subjects whose IGA at each visit is 0 or 1, or improved to 2 or higher		3 years
Secondary	Percentage of subjects whose SCORing Atopic Dermatitis (SCORAD) INDEX was decreased from baseline by more than 50% at each visit (SCORAD-50)		3 years
Secondary	Rate of change in SCORAD index from baseline at each visit		3 years
Secondary	Change in SCORAD index from baseline at each visit	SCORAD index range is from 0 (clear) to 103 (severe)	3 years
Secondary	Rate of change in Body Surface Area(BSA) of the lesion from baseline		3 years
Secondary	Change in Body Surface Area(BSA) of the lesion from baseline	BSA range is from 0 (clear) to 100 (severe)	3 years
Secondary	Change in total serum Immunoglobulin E(IgE) from baseline		3 years