E-cadherin and Integrin Alpha v Beta 1 in Vitiligo

Not Applicable

• Conditions: Vitiligo
• Interventions: Device: Narrow band UVB

• Registration Number: NCT05287776
• Lead Sponsor: Kasr El Aini Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-01
• Study First Submitted: 2021-09-22
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-10
• Last Update Submitted: 2022-03-10
• Study First Posted: 2022-03-18
• Last Update Posted: 2022-03-18
• Primary Completion: 2022-05-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
15 patients with vitiligo subjected to NB-UVB	Narrow band UVB	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.

Primary Outcome Measures

Name	Time	Method
Melanocyte marker (Melan A) for staining of melanocytes	4 months	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.
E-cadherin expression as a cell adhesion molecule between melanocytes and keratinocytes	4 months	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.
Integrin alpha v beta 1 expression as a cell adhesion molecule between melanocytes and keratinocytes	4 months	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.

Secondary Outcome Measures

Name	Time	Method
Vitiligo Area and severity index (VASI)	4 months	Minimum value is 0, maximum value is 100 Higher scores mean worse outcome

Trial Locations

Locations (1)

Kasr El Ainy university hospital, Faulty of medicine,Cairo university; 🇪🇬 Cairo, El Manial, Egypt