Atopic DermatitisNCT04087863
Administration for Placebo Group and 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, 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Not applicable(observational study)
- How many people
- 99 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Aug 2019to 31 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Moderate to Severe Atopic Dermatitis
Who may be able to join
- Subject who enrolled K0102 Clinical Trial(parent study) and be assigned to a placebo group
- Subjects who understand and voluntarily sign an informed consent form
Who cannot join
- Subjects with medical history or surgery/procedure history
- 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)
- Pregnant, breast-feeding women or women who plan to become pregnant during six months after administering the clinical trial medication
- Subjects who participate in other clinical trial or participated in other clinical trial within 4 weeks
- In case follow-up is not possible 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, 1 recruiting
- Recruiting
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, 06591
Sukyung Park, +82-2-2258-8196
About this study
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
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
- 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 (13)
Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 75% at each visit (EASI-75)
Measured: 3 years
Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 50% at each visit (EASI-50)
Measured: 3 years
Rate of change in EASI from baseline
EASI range is from 0 (clear) to 72 (severe)
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
IGA score is from 0 (clear) to 5 (severe)
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 Extent, Intensity of lesions and subject symptoms for SCORAD index from baseline at each visit
Measured: 3 years
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)
Measured: 3 years
Change in total serum Immunoglobulin E(IgE) from baseline
Measured: 3 years
Rate of 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 posted12 Sep 2019
- Study start29 Aug 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 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
- 99 participants (estimated)
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
- NCT04087863
- Sponsor's protocol ID
- K0103
- Status last verified
- Sep 2019
- First submitted
- 11 Sep 2019
- Last updated
- 12 Sep 2019
- 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 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04087863
- Acronym / sponsor ID
- K0103
- Conditions
- Atopic Dermatitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Kang Stem Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Aug 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 Sep 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, 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
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
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Moderate to Severe Atopic Dermatitis
Key inclusion criteria (2 listed)
- Subject who enrolled K0102 Clinical Trial(parent study) and be assigned to a placebo group
- Subjects who understand and voluntarily sign an informed consent form
Key exclusion criteria (6 listed)
- Subjects with medical history or surgery/procedure history
- 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)
- Pregnant, breast-feeding women or women who plan to become pregnant during six months after administering the clinical trial medication
- Subjects who participate in other clinical trial or participated in other clinical trial within 4 weeks
- In case follow-up is not possible to end of this study period
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
13 secondary outcomes
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
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
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 Extent, Intensity of lesions and subject symptoms for SCORAD index from baseline at each visit
Time frame: 3 years
Change in Extent, Intensity of lesions and subject symptoms for SCORAD index from baseline at each visit
Time frame: 3 years
Change in total serum Immunoglobulin E(IgE) from baseline
Time frame: 3 years
Rate of 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 12 Sep 2019.
- 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.
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 6 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 12 Sep 2019. 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?
Contact Seulbi Lee (+82-2-888-1592, sblee@kangstem.com), or a site near the patient. 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 12 Sep 2019.