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Status unknownNCT04087863Updated Sep 12, 2019

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

An observational study in Atopic Dermatitis, sponsored by Kang Stem Biotech Co., Ltd.. Status unknown at 1 site in Korea, Republic of. Per ClinicalTrials.gov, last updated 2019-09-12.

Sponsored by Kang Stem Biotech Co., Ltd. · Observational

The sponsor has not verified this record recently (last verified Sep 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
99
Sex
All
01

Study 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

02

Conditions studied

  • Atopic Dermatitis
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's planned enrollment of 99 is below the median of 150 across 237 observational studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Kang Stem Biotech Co., Ltd. is the lead sponsor of 18 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Moderate to Severe Atopic Dermatitis

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
99 participants (estimated)
Patient registry
No

Groups and cohorts

  • Atopic Dermatitis

    Other: Not applicable(observational study)

Interventions

  • OtherNot applicable(observational study)

    Not applicable(observational study)

06

What researchers measure

Primary outcomes

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

    Time frame: 5 years

Secondary outcomes

  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

    EASI range is from 0 (clear) to 72 (severe)

    Time frame: 3 years

  4. Change in EASI from baseline

    EASI range is from 0 (clear) to 72 (severe)

    Time frame: 3 years

  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

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

    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

    SCORAD index range is from 0 (clear) to 103 (severe)

    Time frame: 3 years

  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

    SCORAD index range is from 0 (clear) to 103 (severe)

    Time frame: 3 years

  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

07

Study locations

1 of 1 sites recruiting
  • The Catholic University of Korea, Seoul ST. Mary's Hospital
    Seoul, 06591, Korea, Republic of
    • Sukyung Park · Contact · +82-2-2258-8196
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04087863
Lead sponsor
Kang Stem Biotech Co., Ltd.
Responsible party
Sponsor
First posted
Sep 12, 2019
Start date
Aug 29, 2019
Primary completion
Dec 31, 2022 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Sep 12, 2019

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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