CClinicalTrials.gg
CompletedNCT03741738Updated Oct 19, 2020

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 in Vitiligo, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-19.

Sponsored by Yonsei University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
43
Ages
19 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Vitiligo

Browse trials for

03

In context

Vitiligo

298 studies on the registry are indexed under Vitiligo; 69 are open to participants now.

This study's enrollment of 43 is below the median of 111 across 60 observational studies indexed under Vitiligo.

Browse Vitiligo studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

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

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients who visted Severance hospital due to vitiligo

Inclusion criteria

  1. 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

  2. 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.
  3. Normal control A. Subjects aged 19 or older who do not have not only vitiligo but also other skin and systemic diseases
  4. Subjects who voluntarily signed a written consent before he / she fully explained the purpose and contents of the examination prior to clinical research
  5. Subjects who can follow up during the clinical study

Exclusion criteria

Exclusion Criteria:

  1. Patients diagnosed with nevus depigmentosus in vitiligo group
  2. Patients under the age of 19
  3. Patients taking steroids and immunosuppressants within the last 4 weeks
  4. Patients using steroids and immunomodulatory ointment within the last 2 weeks
  5. Patients who have been treated with short-wave UV therapy and excimer laser within the last month
  6. Subjects with a disease known to have elevated blood levels of HMGB1 (lupus, systemic cirrhosis Symptoms, infectious diseases, etc.) on normal group
  7. Subjects do not want it or did not fill out a consent form
  8. Subjects who are pregnant or lactating
  9. 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
  10. 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)
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
43 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Serum HMGB1

    Comparative analysis of serum HMGB1 between active non-segmental vitiligo and normal controls

    Time frame: Baseline

Secondary outcomes

  1. Serum HMGB1

    Analysis of serum HMGB1 between segmental vitiligo and normal control

    Time frame: 3 months

07

Study locations

1 site
  • Department of Dermatology, Severance Hospital, Cutaneous Biology Research Institute, Yonsei University College of Medicine
    Seoul, 03722, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

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 Oct 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03741738
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Nov 15, 2018
Start date
Aug 30, 2018
Primary completion
Jun 9, 2020
Completion
Jun 9, 2020
Last update
Oct 19, 2020

Oversight

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

Not currently enrolling

This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion