Latanoprost Plus NB-UVB Versus Each Alone in Non-segmental Vitiligo: Clinical and Laboratory Evaluation

Study Overview
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Brief Summary
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The aim of the study is to evaluate the efficacy of different lines of therapies on the TWEAK serum level in patients with non-segmental vitiligo.

Detailed Description
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the study is to evaluate the efficacy of NB-UVB, latanoprost, and combination of them on the TWEAK serum level in patients with non-segmental vitiligo.

Official Title
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Latanoprost Plus NB-UVB Versus Each Alone in Non-segmental Vitiligo: Clinical and Laboratory Evaluation

Conditions
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Non-segmental Vitiligo

Intervention / Treatment
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* Radiation: NB-UVB
* Drug: Latanoprost


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with non-segmental vitiligo of any age and gender. Exclusion Criteria: History of vitiligo treatment with topical, systemic or biological agents prior to the study for at least 3 weeks. Pregnancy and lactation. Infections Patients with other autoimmune diseases. Patients with chronic diseases: cardiac diseases, hepatic disorders, hematologic disease, chronic renal failure or malignancies.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NB-UVB radiation<br>will expose to 2 sessions/week of NB-UVB radiation, for 3 months. | Radiation: NB-UVB<br>* radiation<br>* Other names: narrow band ultraviolet B;|
| Active Comparator: Latanoprost<br>latanoprost 0.005%, will be applied after microneedling, by using 1.5-2 mm needle length dermapen, of vitiligenous patches. The procedure will be repeated once weekly for 3 months (12 sessions). | Drug: Latanoprost<br>* eye drops<br>* Other names: latanoprost eye drops;|
| Active Comparator: latanoprost + NB-UVB<br>(latanoprost + NB-UVB group): latanoprost 0.005%, will be applied after microneedling of vitiligenous patches in the same day of NB-UVB sessions in the same manner of group 2. | Radiation: NB-UVB<br>* radiation<br>* Other names: narrow band ultraviolet B;Drug: Latanoprost<br>* eye drops<br>* Other names: latanoprost eye drops;|
| No Intervention: healthy individuals<br>healthy individuals as control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum TWEAK in vitiligo | measurement of serum Tumor necrosis factor weak inducer of apoptosis (TWEAK)pg/ml; in vitiligo patients before and after treatment with NB-UVB, Latanoprost and their combination, all in comparison with healthy individuals, using ELISA (enzyme-linked immunosorbent assay) | 3months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment of vitiligo | clinical evaluation: Assessment of the disease severity in non-segmental vitiligo will be performed by using vitiligo area severity index (VASI score) before and after treatment with NB-UVB, latanoprost application applied after microneedling, by using 1.5-2 mm needle length dermapen, of vitiligenous patches, or combination of both of them. Patients will be photographed at baseline and after 3 months of regular treatment by using high resolution digital camera conon EOS 1300D 18 megapixels (made in Taiwan), photography will be done in standard light and distance. | 3 months |