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

Recruiting

• Conditions: Atopic Dermatitis
• Interventions: Other: Not applicable(observational study)

• Registration Number: NCT04087863
• Lead Sponsor: Kang Stem Biotech Co., Ltd.

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-29
• Status Verified: 2019-09
• Study First Submitted: 2019-09-11
• Study First Submitted QC: 2019-09-11
• Last Update Submitted: 2019-09-11
• Study First Posted: 2019-09-12
• Last Update Posted: 2019-09-12
• Primary Completion: 2022-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 99

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Atopic Dermatitis	Not applicable(observational study)	-

Primary Outcome Measures

Name	Time	Method
Safety Assessment (Rate of Adverse Event, Number of Participants with Adverse Event)	5 years

Secondary Outcome Measures

Name	Time	Method
Percentage of subjects whose Investigator's Global Assessment (IGA) score at each visit is 0 or 1	3 years
Percentage of subjects whose IGA at each visit is 0 or 1, or improved to 2 or higher	3 years	IGA score is from 0 (clear) to 5 (severe)
Percentage of subjects whose SCORing Atopic Dermatitis (SCORAD) INDEX was decreased from baseline by more than 50% at each visit (SCORAD-50)	3 years
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
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
Rate of change in EASI from baseline	3 years	EASI range is from 0 (clear) to 72 (severe)
Change in EASI from baseline	3 years	EASI range is from 0 (clear) to 72 (severe)
Change in Extent, Intensity of lesions and subject symptoms for SCORAD index from baseline at each visit	3 years	SCORAD index range is from 0 (clear) to 103 (severe)
Change in total serum Immunoglobulin E(IgE) from baseline	3 years
Rate of change in total serum Immunoglobulin E(IgE) from baseline	3 years
Rate of change in SCORAD index from baseline at each visit	3 years
Change in SCORAD index from baseline at each visit	3 years	SCORAD index range is from 0 (clear) to 103 (severe)
Rate of change in Extent, Intensity of lesions and subject symptoms for SCORAD index from baseline at each visit	3 years

Trial Locations

Locations (1)

The Catholic University of Korea, Seoul ST. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of