Atopic DermatitisNCT03962387
Evalution the Safety and Efficacy in Atopic Dermatitis Patients
An observational study of Atopic Dermatitis, run by Kang Stem Biotech Co., Ltd. at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Not applicable(observational study)
- How many people
- 98 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Apr 2019to 2 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: moderate to severe chronic atopic dermatitis
Who may be able to join
- Subject who enrolled K0102 Clinical Trial(parent study).
- Subjects who understand and voluntarily sign an informed consent form
Who cannot join
- In case follow-up is not possible from end of K0102 clinical trial to end of this study period
- Any other condition which the investigator judges would make patient unsuitable for study participation
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul
About this study
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
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
- Conditions
- Atopic Dermatitis
- Being tested
- Not applicable(observational study)
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable(observational study)Other
Not applicable(observational study)
| Study group | Role | What they receive |
|---|---|---|
| Atopic Dermatitis | Not described Receives: Other: Not applicable(observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Assessment (Rate of Adverse Event, Number of Participants with Adverse Event)
Measured: 5 years
Secondary outcomes (12)
Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 50% at Week 12 (EASI-50)
Measured: 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)
Measured: 3 years
Rate of change in EASI from baseline
Measured: 3 years
Change in EASI from baseline
EASI range is from 0 (clear) to 72 (severe)
Measured: 3 years
Percentage of subjects whose Investigator's Global Assessment (IGA) score at each visit is 0 or 1
Measured: 3 years
Percentage of subjects whose IGA at each visit is 0 or 1, or improved to 2 or higher
Measured: 3 years
Percentage of subjects whose SCORing Atopic Dermatitis (SCORAD) INDEX was decreased from baseline by more than 50% at each visit (SCORAD-50)
Measured: 3 years
Rate of change in SCORAD index from baseline at each visit
Measured: 3 years
Change in SCORAD index from baseline at each visit
SCORAD index range is from 0 (clear) to 103 (severe)
Measured: 3 years
Rate of change in Body Surface Area(BSA) of the lesion from baseline
Measured: 3 years
Change in Body Surface Area(BSA) of the lesion from baseline
BSA range is from 0 (clear) to 100 (severe)
Measured: 3 years
Change in total serum Immunoglobulin E(IgE) from baseline
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start5 Apr 2019
- Primary completion2 Jan 2024 (estimated)
- Study completion2 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kang Stem Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962387
- Sponsor's protocol ID
- K0102-E
- Status last verified
- Jun 2021
- First submitted
- 28 Nov 2018
- Last updated
- 16 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03962387
- Acronym / sponsor ID
- K0102-E
- Conditions
- Atopic Dermatitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Kang Stem Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Apr 2019 (actual)
- Primary completion
- 2 Jan 2024 (estimated)
- Study completion
- 2 Jan 2024 (estimated)
- First posted
- 24 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atopic Dermatitis | – | Other: Not applicable(observational study) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- moderate to severe chronic atopic dermatitis
Key inclusion criteria (2 listed)
- Subject who enrolled K0102 Clinical Trial(parent study).
- Subjects who understand and voluntarily sign an informed consent form
Key exclusion criteria (2 listed)
- In case follow-up is not possible from end of K0102 clinical trial to end of this study period
- Any other condition which the investigator judges would make patient unsuitable for study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable(observational study)Not applicable(observational study) | Other | Atopic Dermatitis |
Primary outcome
Safety Assessment (Rate of Adverse Event, Number of Participants with Adverse Event)
Time frame: 5 years
12 secondary outcomes
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
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
Rate of change in EASI from baseline
Time frame: 3 years
Change in EASI from baseline
Time frame: 3 years
Percentage of subjects whose Investigator's Global Assessment (IGA) score at each visit is 0 or 1
Time frame: 3 years
Percentage of subjects whose IGA at each visit is 0 or 1, or improved to 2 or higher
Time frame: 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
Rate of change in SCORAD index from baseline at each visit
Time frame: 3 years
Change in SCORAD index from baseline at each visit
Time frame: 3 years
Rate of change in Body Surface Area(BSA) of the lesion from baseline
Time frame: 3 years
Change in Body Surface Area(BSA) of the lesion from baseline
Time frame: 3 years
Change in total serum Immunoglobulin E(IgE) from baseline
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by Kang Stem Biotech Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Assessment (Rate of Adverse Event, Number of Participants with Adverse Event) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2021.