E-cadherin and Integrin Alpha v Beta 1 in Vitiligo

NCT05287776 | Unknown

• 1 other identifier: EcadVitiligo
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Vitiligo Area and severity index (VASI)

  4 months

Other Outcomes (1)

• Vitiligo Disease Activity score (VIDA)

  4 months

Study Arms (1)

15 patients with vitiligo subjected to NB-UVB

EXPERIMENTAL

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

Interventions

Narrow band UVB DEVICE

Narrow band UVB emitting UVB at wavelength 311nm

15 patients with vitiligo subjected to NB-UVB

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr El Ainy university hospital, Faulty of medicine,Cairo university

Cairo, El Manial, 11956, Egypt

Location

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of dermatology

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: March 18, 2022
• Study Start: June 1, 2019
• Primary Completion: May 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 18, 2022

Record last verified: 2022-03

Locations

EG (1)