Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (NB-UVB Monotherapy) | Experimental | Standard phototherapy without additional systemic treatment. |
|
| Group 2 (NB-UVB + OMP Steroids) | Experimental | Combination therapy of NB-UVB + OMP Steroids to enhance immunosuppression and repigmentation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NB-UVB twice weekly | Radiation | Standard phototherapy without additional systemic treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum CXCL11 & TEMRA levels | Measured via ELISA before and after treatment. | 6 months |
Not provided
Not provided
Inclusion Criteria:
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).
Exclusion Criteria:
Photosensitivity disorders (e.g., lupus, porphyria).
Pregnancy or breastfeeding.
Active infections, malignancies, or immunosuppressive conditions.
History of hypertrophic scarring or melanoma.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| NB-UVB + dexamethasone (2.5-3 mg/week) | Other | Combination therapy to enhance immunosuppression and repigmentation. |
|
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |