E-cadherin and Integrin Alpha v Beta 1 in Vitiligo

Vitiligo Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05287776
• Other study ID #: EcadVitiligo
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: December 1, 2022

Study information

• Verified date: March 2022
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: December 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vitiligo

Intervention

Device:
• Narrow band UVB
Narrow band UVB emitting UVB at wavelength 311nm

Locations

Country	Name	City	State
Egypt	Kasr El Ainy university hospital, Faulty of medicine,Cairo university	Cairo	El Manial

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Vitiligo Disease Activity score (VIDA)	Minimum value -1, maximum value 4 Higher scores mean worse outcome	4 months
Primary	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
Primary	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
Primary	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	Vitiligo Area and severity index (VASI)	Minimum value is 0, maximum value is 100 Higher scores mean worse outcome	4 months