VitiligoNCT06946069
Immunomodulatory Effects of NB-UVB and Steroids in Vitiligo: A Study on CXCL11 and TEMRA Biomarkers
A study testing NB-UVB twice weekly and NB-UVB + dexamethasone (2.5-3 mg/week) in people with Vitiligo and NB-UVB, run by Assiut University.
Trial summary
this is a prospective, randomized controlled trial (RCT) investigating the immunological effects of narrowband UVB (NB-UVB) phototherapy-both as monotherapy and in combination with oral mini-pulse (OMP) steroids-in non-segmental vitiligo patients. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- NB-UVB twice weekly and NB-UVB + dexamethasone (2.5-3 mg/week)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Clinically diagnosed non-segmental vitiligo (stable for ≥3 months).
- Fitzpatrick skin types III-V (common in the Egyptian population).
- No recent systemic therapy for vitiligo (within the last 3 months).
Who cannot join
- Photosensitivity disorders (e.g., lupus, porphyria).
- Pregnancy or breastfeeding.
- Active infections, malignancies, or immunosuppressive conditions.
- History of hypertrophic scarring or melanoma.
About this study
Official title: Expression of CXCL11 & TEMRA in Serum of Vitiligo Patients Treated With Narrow-band UVB
this is a prospective, randomized controlled trial (RCT) investigating the immunological effects of narrowband UVB (NB-UVB) phototherapy-both as monotherapy and in combination with oral mini-pulse (OMP) steroids-in non-segmental vitiligo patients. The study evaluates changes in CXCL11 (a chemokine involved in T-cell recruitment) and TEMRA (terminally differentiated effector memory T cells re-expressing CD45RA) levels in serum before and after treatment.
Read the detailed description
Design:
Randomized controlled trial (RCT) with two parallel arms.
Duration: Six months (including baseline and follow-up assessments).
Setting: Outpatient dermatology clinic at Assiut University Hospital, Egypt.
Objectives:
Compare the immunomodulatory effects of NB-UVB alone vs. NB-UVB + OMP steroids in vitiligo patients.
Assess CXCL11 and TEMRA levels as potential biomarkers for disease activity and treatment response.
Evaluate clinical repigmentation using Vitiligo Extent Score (VES/VESplus).
Methodology:
40 patients with stable non-segmental vitiligo will be enrolled.
20 patients will undergo serum analysis for CXCL11 and TEMRA via ELISA.
Treatment arms:
NB-UVB monotherapy (twice weekly).
NB-UVB + OMP steroids (dexamethasone 2.5-3 mg/week).
Follow-up: Clinical and immunological assessments at baseline and 6 months.
- Being tested
- NB-UVB twice weekly, NB-UVB + dexamethasone (2.5-3 mg/week)
- Keywords
- vitiligo, NB-UVB, CXCL11, TEMRA
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NB-UVB twice weeklyRadiation
Standard phototherapy without additional systemic treatment.
NB-UVB + dexamethasone (2.5-3 mg/week)Other
Combination therapy to enhance immunosuppression and repigmentation.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (NB-UVB Monotherapy) | Experimental | Standard phototherapy without additional systemic treatment. Receives: Radiation: NB-UVB twice weekly |
| Group 2 (NB-UVB + OMP Steroids) | Experimental | Combination therapy of NB-UVB + OMP Steroids to enhance immunosuppression and repigmentation. Receives: Other: NB-UVB + dexamethasone (2.5-3 mg/week) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum CXCL11 & TEMRA levels
Measured via ELISA before and after treatment.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
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.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-arm, parallel-group randomized controlled trial (RCT). Participants are randomly assigned (1:1 ratio) to one of two treatment arms: NB-UVB monotherapy (control group). NB-UVB + oral mini-pulse (OMP) steroids (intervention group). Both groups receive simultaneous but distinct interventions for direct comparison.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ALZAHRA MOAHMED MOHAMED ABDELHAFEZ, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946069
- Sponsor's protocol ID
- Effects of NB-UVB and Steroids
- Status last verified
- Apr 2025
- First submitted
- 19 Apr 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of CXCL11 & TEMRA in Serum of Vitiligo Patients Treated With Narrow-band UVB
- ClinicalTrials.gov ID
- NCT06946069
- Acronym / sponsor ID
- Effects of NB-UVB and Steroids
- Keywords
- vitiligo, NB-UVB, CXCL11, TEMRA
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 27 Apr 2025 (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 is a prospective, randomized controlled trial (RCT) investigating the immunological effects of narrowband UVB (NB-UVB) phototherapy-both as monotherapy and in combination with oral mini-pulse (OMP) steroids-in non-segmental vitiligo patients. The study evaluates changes in CXCL11 (a chemokine involved in T-cell recruitment) and TEMRA (terminally differentiated effector memory T cells re-expressing CD45RA) levels in serum before and after treatment.
Detailed description
Design:
Randomized controlled trial (RCT) with two parallel arms.
Duration: Six months (including baseline and follow-up assessments).
Setting: Outpatient dermatology clinic at Assiut University Hospital, Egypt.
Objectives:
Compare the immunomodulatory effects of NB-UVB alone vs. NB-UVB + OMP steroids in vitiligo patients.
Assess CXCL11 and TEMRA levels as potential biomarkers for disease activity and treatment response.
Evaluate clinical repigmentation using Vitiligo Extent Score (VES/VESplus).
Methodology:
40 patients with stable non-segmental vitiligo will be enrolled.
20 patients will undergo serum analysis for CXCL11 and TEMRA via ELISA.
Treatment arms:
NB-UVB monotherapy (twice weekly).
NB-UVB + OMP steroids (dexamethasone 2.5-3 mg/week).
Follow-up: Clinical and immunological assessments at baseline and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a two-arm, parallel-group randomized controlled trial (RCT). Participants are randomly assigned (1:1 ratio) to one of two treatment arms: NB-UVB monotherapy (control group). NB-UVB + oral mini-pulse (OMP) steroids (intervention group). Both groups receive simultaneous but distinct interventions for direct comparison.
| Arm | Type | Receives |
|---|---|---|
| Group 1 (NB-UVB Monotherapy) | Experimental | Radiation: NB-UVB twice weeklyStandard phototherapy without additional systemic treatment. |
| Group 2 (NB-UVB + OMP Steroids) | Experimental | Other: NB-UVB + dexamethasone (2.5-3 mg/week)Combination therapy of NB-UVB + OMP Steroids to enhance immunosuppression and repigmentation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Clinically diagnosed non-segmental vitiligo (stable for ≥3 months).
- Fitzpatrick skin types III-V (common in the Egyptian population).
- No recent systemic therapy for vitiligo (within the last 3 months).
Key exclusion criteria (4 listed)
- Photosensitivity disorders (e.g., lupus, porphyria).
- Pregnancy or breastfeeding.
- Active infections, malignancies, or immunosuppressive conditions.
- History of hypertrophic scarring or melanoma.
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 |
|---|---|---|
| NB-UVB twice weeklyStandard phototherapy without additional systemic treatment. | Radiation | Group 1 (NB-UVB Monotherapy) |
| NB-UVB + dexamethasone (2.5-3 mg/week)Combination therapy to enhance immunosuppression and repigmentation. | Other | Group 2 (NB-UVB + OMP Steroids) |
Primary outcome
Change in serum CXCL11 & TEMRA levels
Time frame: 6 months
Measured via ELISA before and after treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing NB-UVB twice weekly and NB-UVB + dexamethasone (2.5-3 mg/week) in people with Vitiligo and NB-UVB, run by Assiut University.
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 4 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: opening soon, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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 serum CXCL11 & TEMRA levels (time frame: 6 months). 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 27 Apr 2025.