E-cadherin and Integrin Alpha v Beta 1 in Vitiligo

NCT ID: NCT05287776

Last Updated: 2022-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2022-12-01

Brief Summary

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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

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Conditions

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Vitiligo

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Narrow band UVB

Intervention Type DEVICE

Narrow band UVB emitting UVB at wavelength 311nm

Interventions

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Narrow band UVB

Narrow band UVB emitting UVB at wavelength 311nm

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kasr El Aini Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rana F Hilal, MD

Lecturer of dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Cairo, El Manial, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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EcadVitiligo

Identifier Type: -

Identifier Source: org_study_id

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