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Administration for Placebo Group and 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: NCT04087863
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Kang Stem Biotech Co., Ltd.

Study Description
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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

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

Study Design
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Study Type : Observational
Estimated Enrollment : 99 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : August 29, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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


Outcome Measures
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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 75% at each visit (EASI-75) [ Time Frame: 3 years ]
  2. Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 50% at each visit (EASI-50) [ Time Frame: 3 years ]
  3. Rate of change in EASI from baseline [ Time Frame: 3 years ]
    EASI range is from 0 (clear) to 72 (severe)

  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 ]
    IGA score is from 0 (clear) to 5 (severe)

  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 Extent, Intensity of lesions and subject symptoms for SCORAD index from baseline at each visit [ Time Frame: 3 years ]
  11. Change in Extent, Intensity of lesions and subject symptoms for SCORAD index from baseline at each visit [ Time Frame: 3 years ]
    SCORAD index range is from 0 (clear) to 103 (severe)

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

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Moderate to Severe Atopic Dermatitis
Criteria

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
Contacts and Locations
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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): NCT04087863


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, 06591
Contact: Sukyung Park    +82-2-2258-8196      
Sponsors and Collaborators
Kang Stem Biotech Co., Ltd.
More Information
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Responsible Party: Kang Stem Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT04087863    
Other Study ID Numbers: K0103
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 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