VitiligoNCT05287776
E-cadherin and Integrin Alpha v Beta 1 in Vitiligo
A study testing Narrow band UVB in people with Vitiligo, run by Kasr El Aini Hospital at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitiligo
- What is being tested?
- Narrow band UVB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2019to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Kasr El Ainy university hospital, Faulty of medicine,Cairo university
Cairo, El Manial, 11956
About this study
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
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
- Being tested
- Narrow band UVB
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrow band UVBDevice
Narrow band UVB emitting UVB at wavelength 311nm
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Narrow band UVB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 4 months
Secondary outcomes (1)
Vitiligo Area and severity index (VASI)
Minimum value is 0, maximum value is 100 Higher scores mean worse outcome
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start1 Jun 2019
- Primary completion1 May 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana F Hilal, MD, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287776
- Sponsor's protocol ID
- EcadVitiligo
- Status last verified
- Mar 2022
- First submitted
- 22 Sep 2021
- Last updated
- 18 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05287776
- Acronym / sponsor ID
- EcadVitiligo
- Conditions
- Vitiligo
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 15 patients with vitiligo subjected to NB-UVB | Experimental | Device: Narrow band UVBPatients 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Narrow band UVBNarrow band UVB emitting UVB at wavelength 311nm | Device | 15 patients with vitiligo subjected to NB-UVB |
Primary outcome
Melanocyte marker (Melan A) for staining of melanocytes
Time frame: 4 months
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
Time frame: 4 months
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
Time frame: 4 months
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.
1 secondary outcome
Vitiligo Area and severity index (VASI)
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrow band UVB in people with Vitiligo, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Melanocyte marker (Melan A) for staining of melanocytes (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.