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临床试验/NCT07796893
NCT07796893已完成不适用

Expression of Exosomal Markers (CD63 and CD9) in Lesional Skin of Vitiligo Patients Before and After Narrow-Band Ultraviolet B Therapy: An Immunohistochemical Study

Amany El-Agamy Ibrahim El-Samadony1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年5月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Change in CD63 Immunohistochemical Expression Before and After NB-UVB Therapy

研究概览

简要总结

This study evaluated the expression of the exosomal markers CD63 and CD9 in the skin of patients with vitiligo and assessed changes in their expression after narrow-band ultraviolet B (NB-UVB) therapy. Twenty patients with vitiligo were included and received NB-UVB therapy for 3 months. Clinical disease activity and severity were assessed using the Vitiligo Disease Activity (VIDA) score and the Vitiligo Area Severity Index (VASI) before and after treatment. Before treatment, skin biopsies were obtained from lesional and perilesional skin. After treatment, skin biopsies were obtained from repigmented areas. The tissue specimens were evaluated histopathologically and by immunohistochemical staining for CD63 and CD9. Twenty normal skin specimens obtained during plastic surgery were used as healthy controls for comparison.

详细描述

Patients with clinically and dermoscopically diagnosed vitiligo were enrolled from the outpatient clinic of the Dermatology and Venereology Department, Tanta University Hospitals. Eligible patients had not received treatment for vitiligo during the 3 months before enrollment and provided written informed consent. At baseline, all patients underwent complete history taking, general and dermatological examination, assessment of disease activity using the Vitiligo Disease Activity (VIDA) score, and assessment of disease severity using the Vitiligo Area Severity Index (VASI). Before treatment, 4-mm punch biopsies were obtained from lesional and perilesional skin. The tissue specimens were formalin-fixed, paraffin-embedded, and processed for routine hematoxylin and eosin staining and immunohistochemical evaluation of the exosomal markers CD63 and CD9. Patients then received narrow-band ultraviolet B (NB-UVB) therapy for 3 months. After treatment, patients were clinically reassessed using VIDA and VASI. A 4-mm punch biopsy was obtained from repigmented skin to evaluate post-treatment changes in CD63 and CD9 expression. Twenty normal skin specimens obtained during plastic surgery were used as healthy controls. The expression of CD63 and CD9 was compared among lesional skin, perilesional skin, post-treatment repigmented skin, and normal control skin.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients already diagnosed with vitiligo clinically and by dermoscopy.
  • Patients who did not receive any treatment for vitiligo for 3 months before joining the study.
  • Patients who accepted to be enrolled in the study and signed an informed consent.

排除标准

  • Pregnant or lactating females.
  • Patients with allergy to local anesthesia.
  • Patients with a history of chronic debilitating diseases, autoimmune disorders, or other systemic diseases.
  • Patients with other dermatological diseases.
  • Patients with a history of bleeding disorders or receiving anticoagulant therapy.
  • Patients with a history of keloid or abnormal scar formation.

研究组 & 干预措施

NB-UVB Therapy

Experimental

Twenty patients with vitiligo received narrow-band ultraviolet B (NB-UVB) therapy for 3 months. Clinical assessment using VIDA and VASI and skin biopsies for histopathological and immunohistochemical evaluation of CD63 and CD9 were performed before and after treatment.

干预措施: Narrow-Band Ultraviolet B (NB-UVB) Therapy (Radiation)

结局指标

主要结局

Change in CD63 Immunohistochemical Expression Before and After NB-UVB Therapy

时间窗: Baseline and after 3 months of NB-UVB therapy

CD63 expression was assessed by immunohistochemical staining in lesional skin at baseline and in repigmented skin after 3 months of narrow-band ultraviolet B (NB-UVB) therapy. CD63 expression was also compared with healthy control skin specimens.

Change in CD9 Immunohistochemical Expression Before and After NB-UVB Therapy

时间窗: Baseline and after 3 months of NB-UVB therapy

CD9 expression was assessed by immunohistochemical staining in lesional skin at baseline and in repigmented skin after 3 months of narrow-band ultraviolet B (NB-UVB) therapy. CD9 expression was also compared with healthy control skin specimens..

Change in CD63 Immunohistochemical Expression Before and After NB-UVB Therapy.

时间窗: Baseline and after 3 months of NB-UVB therapy.

CD63 expression was assessed by immunohistochemical staining in lesional skin at baseline and in repigmented skin after 3 months of narrow-band ultraviolet B (NB-UVB) therapy. CD63 expression was also compared with healthy control skin specimens.

Change in CD9 Immunohistochemical Expression Before and After NB-UVB Therapy.

时间窗: Baseline and after 3 months of NB-UVB therapy.

CD9 expression was assessed by immunohistochemical staining in lesional skin at baseline and in repigmented skin after 3 months of narrow-band ultraviolet B (NB-UVB) therapy. CD9 expression was also compared with healthy control skin specimens.

次要结局

  • Change in Vitiligo Area Severity Index (VASI) After NB-UVB Therapy(Baseline and after 3 months of NB-UVB therapy)
  • Change in Vitiligo Disease Activity (VIDA) Score After NB-UVB Therapy(Baseline and after 3 months of NB-UVB therapy)

研究者

发起方
Amany El-Agamy Ibrahim El-Samadony
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Amany El-Agamy Ibrahim El-Samadony

Assistant Lecturer in Dermatology and Venereology

Tanta University

研究点 (1)

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