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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07796893
Enrollment
20
Registered
2026-09-01
Start date
2024-05-20
Completion date
2026-01-01
Last updated
2026-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitiligo

Keywords

CD63, CD9, Exosomal markers, Narrow-band ultraviolet B, NB-UVB, Immunohistochemistry, Vitiligo area severity index

Brief summary

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.

Detailed description

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.

Interventions

RADIATIONNarrow-Band Ultraviolet B (NB-UVB) Therapy

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

Sponsors

Amany El-Agamy Ibrahim El-Samadony
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

A single group of patients with vitiligo received narrow-band ultraviolet B (NB-UVB) therapy for 3 months. Clinical and immunohistochemical assessments were performed before and after treatment. Normal skin specimens were used only as healthy controls for biomarker comparison and were not assigned to an intervention.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

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

MeasureTime frameDescription
Change in Vitiligo Area Severity Index (VASI) After NB-UVB TherapyBaseline and after 3 months of NB-UVB therapyVitiligo severity was assessed using the Vitiligo Area Severity Index (VASI), which ranges from 0 to 100. Higher scores indicate greater extent and severity of depigmentation and therefore a worse outcome. VASI was assessed at baseline and reassessed after 3 months of narrow-band ultraviolet B (NB-UVB) therapy to evaluate clinical response to treatment.
Change in Vitiligo Disease Activity (VIDA) Score After NB-UVB TherapyBaseline and after 3 months of NB-UVB therapyVitiligo disease activity was assessed using the Vitiligo Disease Activity (VIDA) score, a 6-point scale ranging from -1 to +4. Higher scores indicate greater disease activity and therefore a worse outcome, while lower scores indicate more stable disease. VIDA was assessed at baseline and reassessed after 3 months of narrow-band ultraviolet B (NB-UVB) therapy.

Countries

Egypt

Contacts

PRINCIPAL_INVESTIGATORAmany El-Samadony, MSc

Tanta University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 4, 2026