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

NCT07796893 | Completed

• 2 other identifiers: TU-DERM-EXO-VIT-2024-0536265MD231/5/24
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitiligo

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change in CD63 Immunohistochemical Expression Before and After 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.

  Baseline and after 3 months of NB-UVB therapy.

• Change in CD9 Immunohistochemical Expression Before and After 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.

  Baseline and after 3 months of NB-UVB therapy.

Secondary Outcomes (2)

• 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

Study Arms (1)

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.

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

Interventions

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.

Also known as: NB-UVB Phototherapy

NB-UVB Therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amany El-Agamy Ibrahim El-Samadony: lead

Study Sites (1)

Tanta University Hospitals

Tanta, Gharbia Governorate, 31527, Egypt

Location

MeSH Terms

Conditions

Vitiligo

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Amany El-Samadony, MSc

  Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer in Dermatology and Venereology

Model Details: 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.

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 1, 2026
• Study Start: May 20, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: September 3, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)