Evalution the Safety and Efficacy in Atopic Dermatitis Patients

June 15, 2021 updated by: Kang Stem Biotech Co., Ltd.

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

98

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • The Catholic University of Korea, Seoul St. Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

moderate to severe chronic atopic dermatitis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Atopic Dermatitis
Other: Not applicable(observational study)
Not applicable(observational study)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety Assessment (Rate of Adverse Event, Number of Participants with Adverse Event)
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in EASI from baseline
Time Frame: 3 years
EASI range is from 0 (clear) to 72 (severe)
3 years
Percentage of subjects whose Investigator's Global Assessment (IGA) score at each visit is 0 or 1
Time Frame: 3 years
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
3 years
Rate of change in SCORAD index from baseline at each visit
Time Frame: 3 years
3 years
Change in SCORAD index from baseline at each visit
Time Frame: 3 years
SCORAD index range is from 0 (clear) to 103 (severe)
3 years
Change in total serum Immunoglobulin E(IgE) from baseline
Time Frame: 3 years
3 years
Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 50% at Week 12 (EASI-50)
Time Frame: 3 years
3 years
Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 75% at Week 12 (EASI-75)
Time Frame: 3 years
3 years
Rate of change in EASI from baseline
Time Frame: 3 years
3 years
Percentage of subjects whose IGA at each visit is 0 or 1, or improved to 2 or higher
Time Frame: 3 years
3 years
Rate of change in Body Surface Area(BSA) of the lesion from baseline
Time Frame: 3 years
3 years
Change in Body Surface Area(BSA) of the lesion from baseline
Time Frame: 3 years
BSA range is from 0 (clear) to 100 (severe)
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kang Stem Biotech Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2019

Primary Completion (Anticipated)

January 2, 2024

Study Completion (Anticipated)

January 2, 2024

Study Registration Dates

First Submitted

November 28, 2018

First Submitted That Met QC Criteria

May 21, 2019

First Posted (Actual)

May 24, 2019

Study Record Updates

Last Update Posted (Actual)

June 16, 2021

Last Update Submitted That Met QC Criteria

June 15, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K0102-E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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