Vitiligo, GeneralizedNCT06546059
Gasdermin D Expression in Generalized Vitiligo Patients After Narrow-band Ultraviolet B Therapy
A study testing narrow band ultraviolet-B in people with Vitiligo, Generalized, run by South Valley University.
Trial summary
The aim of this study is to: 1. Evaluate the role of tissue Gasdermin D expression using immunehistochemstry techniques in patients with generalized vitiligo and compare it with healthy controls. 2. Read more about this study
- Who is it for?
- Ages 10 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitiligo, Generalized
- What is being tested?
- narrow band ultraviolet-B
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Nov 2024
- 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 10 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with stable vitiligo of 6 months duration,
- Both sex and ages(10-75)
Who cannot join
- pregnancy,
- lactation,
- patients under or previous phototherapy,
- patients on other immunosuppressives,
- patients receiving topical or systemic therapy like antioxidants and vitamins were kept off treatment for 2 weeks prior to recruitment into the study.
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this study is to:
- Evaluate the role of tissue Gasdermin D expression using immunehistochemstry techniques in patients with generalized vitiligo and compare it with healthy controls.
- Evaluation expression of tissue Gasdermin D using immunehistochemstry techniques in patients with generalized vitiligo after narrow band ultraviolet B therapy.
- Determine whether there is a relationship between Gasdermin D levels and disease duration and involved body surface area (VISA) in vitiligo patients.
Read the detailed description
The aim of this study is to:
- Evaluate the role of tissue Gasdermin D expression using immunehistochemstry techniques in patients with generalized vitiligo and compare it with healthy controls.
- Evaluation expression of tissue Gasdermin D using immunehistochemstry techniques in patients with generalized vitiligo after narrow band ultraviolet B therapy.
- Determine whether there is a relationship between Gasdermin D levels and disease duration and involved body surface area (VISA) in vitiligo patients.
- Conditions
- Vitiligo, Generalized
- Being tested
- narrow band ultraviolet-B
- 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 ultraviolet-BDevice
vitiligo patients will recevie twice sessions per week
| Study group | Role | What they receive |
|---|---|---|
| one group | Other | Not described Receives: Device: narrow band ultraviolet-B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the role of tissue Gasdermin D expression using immunehistochemstry techniques in patients with generalized vitiligo and compare it with healthy controls.
1- Evaluate the role of tissue Gasdermin D expression using immunehistochemstry techniques in patients with generalized vitiligo and compare it with healthy controls.techniques in patients with generalized vitiligo and compare it with healthy controls.
Measured: three months
Secondary outcomes (2)
2- Evaluation expression of tissue Gasdermin D using immunehistochemstry techniques in patients with generalized vitiligo after narrow band ultraviolet B therapy.
2- Evaluation expression of tissue Gasdermin D using immunehistochemstry techniques in patients with generalized vitiligo after narrow band ultraviolet B therapy.
Measured: three months
3- Determine whether there is a correlation between tissue immunehistochemstry Gasdermin D levels and disease duration and involved body surface area (VISA) in vitiligo patients.
3- Determine whether there is a correlation between tissue immunehistochemstry D levels and disease duration and involved body surface area (VISA) in vitiligo patients.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study startAug 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitiligo, GeneralizedStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soheir Abdelhamid, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546059
- Sponsor's protocol ID
- SVU-MED-,4-24,7,871
- Status last verified
- Aug 2024
- First submitted
- 5 Aug 2024
- Last updated
- 9 Aug 2024
- 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 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gasdermin D Expression in Generalized Vitiligo Patients After Narrow-band Ultraviolet B Therapy
- ClinicalTrials.gov ID
- NCT06546059
- Acronym / sponsor ID
- SVU-MED-,4-24,7,871
- Conditions
- Vitiligo, Generalized
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 9 Aug 2024 (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 aim of this study is to:
- Evaluate the role of tissue Gasdermin D expression using immunehistochemstry techniques in patients with generalized vitiligo and compare it with healthy controls.
- Evaluation expression of tissue Gasdermin D using immunehistochemstry techniques in patients with generalized vitiligo after narrow band ultraviolet B therapy.
- Determine whether there is a relationship between Gasdermin D levels and disease duration and involved body surface area (VISA) in vitiligo patients.
Detailed description
The aim of this study is to:
- Evaluate the role of tissue Gasdermin D expression using immunehistochemstry techniques in patients with generalized vitiligo and compare it with healthy controls.
- Evaluation expression of tissue Gasdermin D using immunehistochemstry techniques in patients with generalized vitiligo after narrow band ultraviolet B therapy.
- Determine whether there is a relationship between Gasdermin D levels and disease duration and involved body surface area (VISA) in vitiligo patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one group | Other | Device: narrow band ultraviolet-B |
Who may qualify
- Ages
- 10 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with stable vitiligo of 6 months duration,
- Both sex and ages(10-75)
Key exclusion criteria (5 listed)
- pregnancy,
- lactation,
- patients under or previous phototherapy,
- patients on other immunosuppressives,
- patients receiving topical or systemic therapy like antioxidants and vitamins were kept off treatment for 2 weeks prior to recruitment into the study.
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 ultraviolet-Bvitiligo patients will recevie twice sessions per week | Device | one group |
Primary outcome
Evaluate the role of tissue Gasdermin D expression using immunehistochemstry techniques in patients with generalized vitiligo and compare it with healthy controls.
Time frame: three months
1- Evaluate the role of tissue Gasdermin D expression using immunehistochemstry techniques in patients with generalized vitiligo and compare it with healthy controls.techniques in patients with generalized vitiligo and compare it with healthy controls.
2 secondary outcomes
2- Evaluation expression of tissue Gasdermin D using immunehistochemstry techniques in patients with generalized vitiligo after narrow band ultraviolet B therapy.
Time frame: three months
3- Determine whether there is a correlation between tissue immunehistochemstry Gasdermin D levels and disease duration and involved body surface area (VISA) in vitiligo patients.
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing narrow band ultraviolet-B in people with Vitiligo, Generalized, run by South Valley University.
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 5 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 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Soheir Abdel-Hamid, MD (01066877343, soher.abdel-hamid@med.svu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the role of tissue Gasdermin D expression using immunehistochemstry techniques in patients with generalized vitiligo and compare it with healthy controls. (time frame: three months). 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 9 Aug 2024.