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Evalution the Safety and Efficacy in Atopic Dermatitis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03962387
Recruitment Status : Recruiting
First Posted : May 24, 2019
Last Update Posted : May 27, 2019
Sponsor:
Information provided by (Responsible Party):
Kang Stem Biotech Co., Ltd.

Brief 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

Condition or disease Intervention/treatment
Atopic Dermatitis Other: Not applicable(observational study)

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Study Type : Observational
Estimated Enrollment : 194 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : April 5, 2019
Estimated Primary Completion Date : January 2, 2024
Estimated Study Completion Date : January 2, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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




Primary Outcome Measures :
  1. Safety Assessment (Rate of Adverse Event, Number of Participants with Adverse Event) [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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. Rate of change in EASI from baseline [ Time Frame: 3 years ]
  4. Change in EASI from baseline [ Time Frame: 3 years ]
    EASI range is from 0 (clear) to 72 (severe)

  5. Percentage of subjects whose Investigator's Global Assessment (IGA) score at each visit is 0 or 1 [ Time Frame: 3 years ]
  6. Percentage of subjects whose IGA at each visit is 0 or 1, or improved to 2 or higher [ Time Frame: 3 years ]
  7. 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 ]
  8. Rate of change in SCORAD index from baseline at each visit [ Time Frame: 3 years ]
  9. Change in SCORAD index from baseline at each visit [ Time Frame: 3 years ]
    SCORAD index range is from 0 (clear) to 103 (severe)

  10. Rate of change in Body Surface Area(BSA) of the lesion from baseline [ Time Frame: 3 years ]
  11. Change in Body Surface Area(BSA) of the lesion from baseline [ Time Frame: 3 years ]
    BSA range is from 0 (clear) to 100 (severe)

  12. Change in total serum Immunoglobulin E(IgE) from baseline [ Time Frame: 3 years ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
moderate to severe chronic atopic dermatitis
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03962387


Contacts
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Contact: Seulbi Lee +82-2-888-1592 sblee@kangstem.com
Contact: Jeong-hyang Woo +82-2-888-1592 jhwoo@kangstem.com

Locations
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Korea, Republic of
The Catholic University of Korea, Seoul ST. Mary's Hospital Recruiting
Seoul, Korea, Republic of
Contact: Dae-eun Cho    +82-2-22588196      
Sponsors and Collaborators
Kang Stem Biotech Co., Ltd.

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Responsible Party: Kang Stem Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT03962387     History of Changes
Other Study ID Numbers: K0102-E
First Posted: May 24, 2019    Key Record Dates
Last Update Posted: May 27, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases