E-cadherin and Integrin Alpha v Beta 1 in Vitiligo

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical trial is to study the effect of Narrow Band UVB on E-cadherin and integrin alpha v beta 1 as representatives of adhesion molecules in non-segmental vitiligo in a trial to verify a novel proposed mechanism of Narrow Band UVB. Additionally, specific melanocyte marker (Melan A) will be done to settle the localization of adhesion molecules in relation to melanocytes.

Official Title
-----------------
The Effect of Narrow Band UVB on E-cadherin and Integrin Alpha v Beta 1 in Non-segmental Vitiligo: A Novel Proposed Mechanism

Conditions
-----------------
Vitiligo

Intervention / Treatment
-----------------
* Device: Narrow band UVB


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All clinically diagnosed cases of non-segmental vitiligo . Patients with VIDA +1 or more (new/expanding lesions active in time period of 6-12 months ago) will be included in the trial. Activity of vitiligo will be evaluated through Vitiligo Disease Activity (VIDA) Score. Exclusion Criteria: Patients who have stable disease at the time of study i.e. no progression of existing disease or appearance of new lesions in the last six months. Patients receiving treatment for vitiligo 3 months prior to the study. Patients with contraindications for phototherapy. Patients with current/history of any systemic and/or dermatological diseases affecting the immune system as autoimmune diseases and malignancy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 15 patients with vitiligo subjected to NB-UVB<br>Patients will be subjected to NB-UVB sessions 3 times weekly. The UVB dosing scheme in the patients receiving only NB-UVB treatment entailed initial dosing at 0.5 J/cm2 with increasing increments by 0.3 J/cm 2 every other session until faint erythema occurs. | Device: Narrow band UVB<br>* Narrow band UVB emitting UVB at wavelength 311nm<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Melanocyte marker (Melan A) for staining of melanocytes | Immunohistochemistry and image analysis Data were obtained using Leica Quinn software with Olympus BX40 microscope and Panasonic camera Measurements were taken in 5 non-overlapping high power fields. | 4 months | 
| E-cadherin expression as a cell adhesion molecule between melanocytes and keratinocytes | Immunohistochemistry and image analysis Data were obtained using Leica Quinn software with Olympus BX40 microscope and Panasonic camera Measurements were taken in 5 non-overlapping high power fields. | 4 months | 
| Integrin alpha v beta 1 expression as a cell adhesion molecule between melanocytes and keratinocytes | Immunohistochemistry and image analysis Data were obtained using Leica Quinn software with Olympus BX40 microscope and Panasonic camera Measurements were taken in 5 non-overlapping high power fields. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitiligo Area and severity index (VASI) | Minimum value is 0, maximum value is 100 Higher scores mean worse outcome | 4 months |