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
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|ClinicalTrials.gov Identifier: NCT03741738|
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : November 15, 2018
|Condition or disease|
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 Type :||Observational|
|Estimated Enrollment :||54 participants|
|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|
|Actual Study Start Date :||August 30, 2018|
|Estimated Primary Completion Date :||August 29, 2020|
|Estimated Study Completion Date :||August 29, 2020|
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.
A. Subjects aged 19 or older who do not have not only vitiligo but also other skin and systemic diseases
- Serum HMGB1 [ Time Frame: Baseline ]Comparative analysis of serum HMGB1 between active non-segmental vitiligo and normal controls
- Serum HMGB1 [ Time Frame: 3 months ]Analysis of serum HMGB1 between segmental vitiligo and normal control
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741738
|Contact: Sang Ho Oh, MD, PhD||+82 2 2228 firstname.lastname@example.org|
|Korea, Republic of|
|Department of Dermatology, Severance Hospital, Cutaneous Biology Research Institute, Yonsei University College of Medicine||Recruiting|
|Seoul, Korea, Republic of, 03722|
|Contact: Sang Ho Oh, MD, PhD +82 2 2228 2080 email@example.com|