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

NCT04087863 | Unknown

• 1 other identifier: K0103
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 1

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

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

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

  5 years

Secondary Outcomes (13)

• 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

• Change in EASI from baseline

  3 years

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

  3 years

Study Arms (1)

Atopic Dermatitis

Other: Not applicable(observational study)

Interventions

Not applicable(observational study) OTHER

Not applicable(observational study)

Atopic Dermatitis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Moderate to Severe Atopic Dermatitis

You may qualify if:

• Subject who enrolled K0102 Clinical Trial(parent study) and be assigned to a placebo group
• Subjects who understand and voluntarily sign an informed consent form

You may not qualify if:

• Subjects with medical history or surgery/procedure history
• 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)
• Pregnant, breast-feeding women or women who plan to become pregnant during six months after administering the clinical trial medication
• Subjects who participate in other clinical trial or participated in other clinical trial within 4 weeks
• In case follow-up is not possible to end of this study period
• Any other condition which the investigator judges would make patient unsuitable for study participation

Sponsors & Collaborators

• Kang Stem Biotech Co., Ltd.: lead

Study Sites (1)

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

Seoul, 06591, South Korea

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Seulbi Lee

CONTACT

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

Jeong-hyang Woo

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: September 12, 2019
• Study Start: August 29, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2024
• Last Updated: September 12, 2019

Record last verified: 2019-09

Locations

KR (1)