E-cadherin and Integrin Alpha v Beta 1 in Vitiligo

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Vitiligo
• Intervention / Treatment: Device: Narrow band UVB

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El Manial
    • Cairo, El Manial, Egypt, 11956
      • Kasr El Ainy university hospital, Faulty of medicine,Cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 15 patients with vitiligo subjected to NB-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.	Device: Narrow band UVB; Narrow band UVB emitting UVB at wavelength 311nm

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vitiligo Disease Activity score (VIDA)	Minimum value -1, maximum value 4 Higher scores mean worse outcome	4 months

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: September 22, 2021
• First Submitted That Met QC Criteria: March 10, 2022
• First Posted (Actual): March 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 18, 2022
• Last Update Submitted That Met QC Criteria: March 10, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation; Vitiligo
• Other Study ID Numbers: EcadVitiligo

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No