VitiligoNCT07796893
Exosomal Markers CD63 and CD9 in Vitiligo Before and After NB-UVB Therapy
A study testing Narrow-Band Ultraviolet B (NB-UVB) Therapy in people with Vitiligo, run by Amany El-Agamy Ibrahim El-Samadony at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vitiligo
- What is being tested?
- Narrow-Band Ultraviolet B (NB-UVB) Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2024to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Conditions
- Vitiligo
- Being tested
- Narrow-Band Ultraviolet B (NB-UVB) Therapy
- Keywords
- CD63, CD9, Exosomal markers, Narrow-band ultraviolet B, NB-UVB, Immunohistochemistry, Vitiligo area severity index
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrow-Band Ultraviolet B (NB-UVB) TherapyRadiation
Also called NB-UVB Phototherapy
Participants with vitiligo received narrow-band ultraviolet B (NB-UVB) phototherapy for 3 months as the study intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Narrow-Band Ultraviolet B (NB-UVB) Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and after 3 months of NB-UVB therapy.
Secondary outcomes (2)
Change in Vitiligo Area Severity Index (VASI) After NB-UVB Therapy
Vitiligo 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.
Measured: Baseline and after 3 months of NB-UVB therapy
Change in Vitiligo Disease Activity (VIDA) Score After NB-UVB Therapy
Vitiligo 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.
Measured: Baseline and after 3 months of NB-UVB therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start20 May 2024
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amany El-Agamy Ibrahim El-Samadony
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amany El-Agamy Ibrahim El-Samadony, Tanta University
- Investigators
- Amany El-Samadony, MSc, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07796893
- Sponsor's protocol ID
- TU-DERM-EXO-VIT-2024-05
- Other IDs
- 36265MD231/5/24
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Study findings will be reported and published only in aggregated form, without information that could identify individual participants.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07796893
- Acronym / sponsor ID
- TU-DERM-EXO-VIT-2024-05
- Conditions
- Vitiligo
- Keywords
- CD63, CD9, Exosomal markers, Narrow-band ultraviolet B, NB-UVB, Immunohistochemistry, Vitiligo area severity index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Amany El-Agamy Ibrahim El-SamadonyUniversity, hospital or other
- Study start
- 20 May 2024 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| NB-UVB Therapy | Experimental | Radiation: Narrow-Band Ultraviolet B (NB-UVB) TherapyTwenty 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Narrow-Band Ultraviolet B (NB-UVB) TherapyAlso: NB-UVB PhototherapyParticipants with vitiligo received narrow-band ultraviolet B (NB-UVB) phototherapy for 3 months as the study intervention. | Radiation | NB-UVB Therapy |
Primary outcome
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.
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.
2 secondary outcomes
Change in Vitiligo Area Severity Index (VASI) After NB-UVB Therapy
Time frame: Baseline and after 3 months of NB-UVB therapy
Change in Vitiligo Disease Activity (VIDA) Score After NB-UVB Therapy
Time frame: Baseline and after 3 months of NB-UVB therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Study findings will be reported and published only in aggregated form, without information that could identify individual participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amany El-Samadony, MSc principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrow-Band Ultraviolet B (NB-UVB) Therapy in people with Vitiligo, run by Amany El-Agamy Ibrahim El-Samadony at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CD63 Immunohistochemical Expression Before and After NB-UVB Therapy. (time frame: Baseline and after 3 months of NB-UVB therapy.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.