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NCT Number: NCT07796893

Exosomal Markers CD63 and CD9 in Vitiligo Before and After NB-UVB Therapy

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University Hospitals

Tanta, Gharbia Governorate, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Narrow-Band Ultraviolet B (NB-UVB) Therapy

Radiation

Participants with vitiligo received narrow-band ultraviolet B (NB-UVB) phototherapy for 3 months as the study intervention

Other names: NB-UVB Phototherapy

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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..

Secondary outcomes

  1. Change in Vitiligo Area Severity Index (VASI) After NB-UVB Therapy

    Time frame: Baseline and after 3 months of NB-UVB therapy

    Vitiligo severity was assessed using the Vitiligo Area Severity Index (VASI) at baseline and reassessed after 3 months of narrow-band ultraviolet B (NB-UVB) therapy to evaluate the clinical response to treatment

  2. Change in Vitiligo Disease Activity (VIDA) Score After NB-UVB Therapy

    Time frame: Baseline and after 3 months of NB-UVB therapy

    Vitiligo disease activity was assessed using the Vitiligo Disease Activity (VIDA) score at baseline and reassessed after 3 months of narrow-band ultraviolet B (NB-UVB) therapy to evaluate changes in disease activity

Sponsors and collaborators

Lead sponsor

Amany El-Agamy Ibrahim El-Samadony

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 1, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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