Back to resultsE-cadherin and Integrin Alpha v Beta 1 in Vitiligo
Primary Purpose
Vitiligo
Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Narrow band UVB
Sponsored by
About this trial
This is an interventional treatment trial for Vitiligo
Eligibility Criteria
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.
Sites / Locations
- Kasr El Ainy university hospital, Faulty of medicine,Cairo university
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
15 patients with vitiligo subjected to NB-UVB
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Vitiligo Area and severity index (VASI)
Minimum value is 0, maximum value is 100 Higher scores mean worse outcome
Full Information
NCT ID
NCT05287776
First Posted
September 22, 2021
Last Updated
March 10, 2022
Sponsor
Kasr El Aini Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05287776
Brief Title
E-cadherin and Integrin Alpha v Beta 1 in Vitiligo
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
May 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
15 patients with vitiligo subjected to NB-UVB
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Narrow band UVB
Intervention Description
Narrow band UVB emitting UVB at wavelength 311nm
Primary Outcome Measure Information:
Title
Melanocyte marker (Melan A) for staining of melanocytes
Description
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.
Time Frame
4 months
Title
E-cadherin expression as a cell adhesion molecule between melanocytes and keratinocytes
Description
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.
Time Frame
4 months
Title
Integrin alpha v beta 1 expression as a cell adhesion molecule between melanocytes and keratinocytes
Description
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.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Vitiligo Area and severity index (VASI)
Description
Minimum value is 0, maximum value is 100 Higher scores mean worse outcome
Time Frame
4 months
Other Pre-specified Outcome Measures:
Title
Vitiligo Disease Activity score (VIDA)
Description
Minimum value -1, maximum value 4 Higher scores mean worse outcome
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Kasr El Ainy university hospital, Faulty of medicine,Cairo university
City
Cairo
State/Province
El Manial
ZIP/Postal Code
11956
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
E-cadherin and Integrin Alpha v Beta 1 in Vitiligo
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