VitiligoNCT03741738
The Investigation on the Expression of High Mobility Group Protein Box-1 (HMGB1) in Peripheral Blood of Vitiligo Patients and Healthy Controls According to Clinical Features, Treatment and Disease Activity
An observational study of Vitiligo, run by Yonsei University at 1 site in South Korea.
Trial summary
Vitiligo is an acquired depigmented disorder that causes white spots on the skin due to the loss of melanocytes. It is a common disease which accounts for 0.5-1% of the whole population. It is a refractory skin disease with 25-50 thousand patients in Korea. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitiligo
- How many people
- 43 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Aug 2018to 9 Jun 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who visted Severance hospital due to vitiligo
Who may be able to join
- Non-segmental vitiligo :
- Patients aged 19 years or older who were clinically diagnosed with non-segmented leukopenia at Severance Hospital.
- Patients (36 patients) who experienced worsening symptoms within the last 3 months and 10 patients whose symptoms were stable within 3 months C. Patients with vitiligo lesion at least 3% of the skin
- Segmental VT or Focal VT A. The investigators evaluated patients who were diagnosed as segmental vitiligo clinically on Severance hospital and who were 19 years old or older.
- Normal control A. Subjects aged 19 or older who do not have not only vitiligo but also other skin and systemic diseases
- Subjects who voluntarily signed a written consent before he / she fully explained the purpose and contents of the examination prior to clinical research
- Subjects who can follow up during the clinical study
Who cannot join
- Patients diagnosed with nevus depigmentosus in vitiligo group
- Patients under the age of 19
- Patients taking steroids and immunosuppressants within the last 4 weeks
- Patients using steroids and immunomodulatory ointment within the last 2 weeks
- Patients who have been treated with short-wave UV therapy and excimer laser within the last month
- Subjects with a disease known to have elevated blood levels of HMGB1 (lupus, systemic cirrhosis Symptoms, infectious diseases, etc.) on normal group
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- Subjects do not want it or did not fill out a consent form
- Subjects who are pregnant or lactating
- Patients whose clinical investigator is deemed unsuitable as a subject for the following patients or other pathologies 1) If the site of treatment has infectious or inflammatory skin disease 2) If the site of treatment has melasma or other pigmented dermatologic disease 3) If subjects have keloid disease, collagen, or elastic fiber disease 4) If subjects have chronic wasting disease (asthma, diabetes, etc.) 5) If subjects are taking anticoagulants and are at risk of bleeding 6) If subjects have an autoimmune disease 7) Subjects with psychiatric problems 8) Acute patients
- Others in addition to the above items, if it is deemed difficult for clinical practice to be conducted at the discretion of the clinical trial manager (including illiteracy and other foreigners exclusion)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Dermatology, Severance Hospital, Cutaneous Biology Research Institute, Yonsei University College of Medicine
Seoul, 03722
About this study
Vitiligo is an acquired depigmented disorder that causes white spots on the skin due to the loss of melanocytes. It is a common disease which accounts for 0.5-1% of the whole population. It is a refractory skin disease with 25-50 thousand patients in Korea. And it is often caused in the exposed areas of the patient, causing a great deal of mental and social dysfunction in the patient's life, and may lead to suicide attempts.
Read the detailed description
A nationwide study conducted by the Korean Academy of vitiligo showed that 61.8% of patients with vitiligo always have emotional impairment. In addition, the incidence of recurrence is high, and the recurrence rate is reported up to 40% within one year after the discontinuation of treatment. Therefore, development of a marker for monitoring the disease activity is very important and desperately needed.
HMGB1 is a protein located in the nucleus, such as histone, and binds to genes and transcription factors to stabilize and control the DNA transcription. However, when released from the cells, it acts as a danger signal and is thought to cause autoimmune diseases such as inflammatory diseases and lupus. The present study demonstrated through ex vivo tissue culture that HMGB1 can induce melanocyte apoptosis by inducing apoptosis and also observed that serum concentration of HMGB1 was higher in vitiligo patients than in normal controls . The aim of this study is to investigate the usefulness of HMGB1 as a biomarker for predicting the severity of disease and to confirm the association between HMGB1 levels and vitiligo activity.
- Conditions
- Vitiligo
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-segmental vitiligo : | A. Patients aged 19 years or older who were clinically diagnosed with non-segmented leukopenia at Severance Hospital. B. Patients (36 patients) who experienced worsening symptoms within the last 3 months and 10 patients whose symptoms were stable within 3 months C. Patients with vitiligo lesion at least 3% of the skin | |
| Segmental VT or Focal VT | A. The investigators evaluated patients who were diagnosed as segmental vitiligo clinically on Severance hospital and who were 19 years old or older. | |
| Normal control | A. Subjects aged 19 or older who do not have not only vitiligo but also other skin and systemic diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum HMGB1
Comparative analysis of serum HMGB1 between active non-segmental vitiligo and normal controls
Measured: Baseline
Secondary outcomes (1)
Serum HMGB1
Analysis of serum HMGB1 between segmental vitiligo and normal control
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start30 Aug 2018
- Primary completion9 Jun 2020
- Study completion9 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03741738
- Sponsor's protocol ID
- 4-2018-0686
- Status last verified
- Oct 2020
- First submitted
- 31 Oct 2018
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigation on the Expression of High Mobility Group Protein Box-1 (HMGB1) in Peripheral Blood of Vitiligo Patients and Healthy Controls According to Clinical Features, Treatment and Disease Activity
- ClinicalTrials.gov ID
- NCT03741738
- Acronym / sponsor ID
- 4-2018-0686
- Conditions
- Vitiligo
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- 9 Jun 2020 (actual)
- Study completion
- 9 Jun 2020 (actual)
- First posted
- 15 Nov 2018 (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.
Vitiligo is an acquired depigmented disorder that causes white spots on the skin due to the loss of melanocytes. It is a common disease which accounts for 0.5-1% of the whole population. It is a refractory skin disease with 25-50 thousand patients in Korea. And it is often caused in the exposed areas of the patient, causing a great deal of mental and social dysfunction in the patient's life, and may lead to suicide attempts.
Detailed description
A nationwide study conducted by the Korean Academy of vitiligo showed that 61.8% of patients with vitiligo always have emotional impairment. In addition, the incidence of recurrence is high, and the recurrence rate is reported up to 40% within one year after the discontinuation of treatment. Therefore, development of a marker for monitoring the disease activity is very important and desperately needed.
HMGB1 is a protein located in the nucleus, such as histone, and binds to genes and transcription factors to stabilize and control the DNA transcription. However, when released from the cells, it acts as a danger signal and is thought to cause autoimmune diseases such as inflammatory diseases and lupus. The present study demonstrated through ex vivo tissue culture that HMGB1 can induce melanocyte apoptosis by inducing apoptosis and also observed that serum concentration of HMGB1 was higher in vitiligo patients than in normal controls . The aim of this study is to investigate the usefulness of HMGB1 as a biomarker for predicting the severity of disease and to confirm the association between HMGB1 levels and vitiligo activity.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-segmental vitiligo : | – | –A. Patients aged 19 years or older who were clinically diagnosed with non-segmented leukopenia at Severance Hospital. B. Patients (36 patients) who experienced worsening symptoms within the last 3 months and 10 patients whose symptoms were stable within 3 months C. Patients with vitiligo lesion at least 3% of the skin |
| Segmental VT or Focal VT | – | –A. The investigators evaluated patients who were diagnosed as segmental vitiligo clinically on Severance hospital and who were 19 years old or older. |
| Normal control | – | –A. Subjects aged 19 or older who do not have not only vitiligo but also other skin and systemic diseases |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who visted Severance hospital due to vitiligo
Key inclusion criteria (7 listed)
- Non-segmental vitiligo :
- Segmental VT or Focal VT A. The investigators evaluated patients who were diagnosed as segmental vitiligo clinically on Severance hospital and who were 19 years old or older.
- Normal control A. Subjects aged 19 or older who do not have not only vitiligo but also other skin and systemic diseases
- Subjects who voluntarily signed a written consent before he / she fully explained the purpose and contents of the examination prior to clinical research
- Subjects who can follow up during the clinical study
Key exclusion criteria (10 listed)
- Patients diagnosed with nevus depigmentosus in vitiligo group
- Patients under the age of 19
- Patients taking steroids and immunosuppressants within the last 4 weeks
- Patients using steroids and immunomodulatory ointment within the last 2 weeks
- Patients who have been treated with short-wave UV therapy and excimer laser within the last month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum HMGB1
Time frame: Baseline
Comparative analysis of serum HMGB1 between active non-segmental vitiligo and normal controls
1 secondary outcome
Serum HMGB1
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Individual participant dataSharing planned: No
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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 Vitiligo, run by Yonsei University 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 7 inclusion and 10 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: finished, as of the sponsor's last update on 19 Oct 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Serum HMGB1 (time frame: Baseline). 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 19 Oct 2020.