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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04087863
• Other study ID #: K0103
• Status: Recruiting
• Start date: August 29, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2019
• Source: Kang Stem Biotech Co., Ltd.
• Contact: Seulbi Lee
• Phone: +82-2-888-1592
• Email: sblee[@]kangstem.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 99
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

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 75% at each visit (EASI-75)		3 years
Secondary	Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 50% at each visit (EASI-50)		3 years
Secondary	Rate of change in EASI from baseline	EASI range is from 0 (clear) to 72 (severe)	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	IGA score is from 0 (clear) to 5 (severe)	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 Extent, Intensity of lesions and subject symptoms for SCORAD index from baseline at each visit		3 years
Secondary	Change in Extent, Intensity of lesions and subject symptoms for SCORAD index from baseline at each visit	SCORAD index range is from 0 (clear) to 103 (severe)	3 years
Secondary	Change in total serum Immunoglobulin E(IgE) from baseline		3 years
Secondary	Rate of change in total serum Immunoglobulin E(IgE) from baseline		3 years