VitiligoNCT03832751
Human Beta-defensin 1 in Vitiligo
A study testing skin biopsy before and after NB-UVB phototherapy in people with Vitiligo, run by Cairo University.
Trial summary
There is a need to know the role of human beta defensin-1 in vitiligo pathogenesis and the probability of finding newer and effective therapy for vitiligo in the future. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitiligo
- What is being tested?
- skin biopsy before and after NB-UVB phototherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Mar 2019to Dec 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with non-segmental vitiligo.
- Both genders.
- Age more than 18 years old.
- New cases or cases not receiving any treatment for at least 3 months prior to the study.
Who cannot join
- Universal or segmental vitiligo.
- Any contraindication to phototherapy treatment.
- History of autoimmune diseases or other systemic diseases.
- Any other skin disease.
About this study
Official title: Estimation of Tissue Level of Human Beta-defensin 1 (HBD-1) in Vitiligo Before and After Narrowband UVB Phototherapy: a Case-control Study
There is a need to know the role of human beta defensin-1 in vitiligo pathogenesis and the probability of finding newer and effective therapy for vitiligo in the future.
- Conditions
- Vitiligo
- Being tested
- skin biopsy before and after NB-UVB phototherapy
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin biopsy before and after NB-UVB phototherapyOther
skin biopsy before and after NB-UVB phototherapy to measure tissue human beta-defensin 1
| Study group | Role | What they receive |
|---|---|---|
| vitiligo patients | Experimental | Tissue levels of human beta-defensin 1 in vitiligo patients before and after NB-UVB phototherapy Receives: Other: skin biopsy before and after NB-UVB phototherapy |
| Healthy controls | Active comparator | Tissue levels of human beta-defensin 1 in healthy controls Receives: Other: skin biopsy before and after NB-UVB phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue levels of human beta-defensin 1 before and after NB-UVB phototherapy
Measured: 6 months to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study startMar 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (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.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Fathy Elmasry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832751
- Sponsor's protocol ID
- Dermatology 12
- Status last verified
- Feb 2019
- First submitted
- 5 Feb 2019
- Last updated
- 6 Feb 2019
- 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 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Tissue Level of Human Beta-defensin 1 (HBD-1) in Vitiligo Before and After Narrowband UVB Phototherapy: a Case-control Study
- ClinicalTrials.gov ID
- NCT03832751
- Acronym / sponsor ID
- Dermatology 12
- Conditions
- Vitiligo
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 6 Feb 2019 (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.
There is a need to know the role of human beta defensin-1 in vitiligo pathogenesis and the probability of finding newer and effective therapy for vitiligo in the future.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitiligo patients | Experimental | Other: skin biopsy before and after NB-UVB phototherapyTissue levels of human beta-defensin 1 in vitiligo patients before and after NB-UVB phototherapy |
| Healthy controls | Active comparator | Other: skin biopsy before and after NB-UVB phototherapyTissue levels of human beta-defensin 1 in healthy controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with non-segmental vitiligo.
- Both genders.
- Age more than 18 years old.
- New cases or cases not receiving any treatment for at least 3 months prior to the study.
Key exclusion criteria (4 listed)
- Universal or segmental vitiligo.
- Any contraindication to phototherapy treatment.
- History of autoimmune diseases or other systemic diseases.
- Any other skin disease.
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 |
|---|---|---|
| skin biopsy before and after NB-UVB phototherapyskin biopsy before and after NB-UVB phototherapy to measure tissue human beta-defensin 1 | Other | Healthy controls, vitiligo patients |
Primary outcome
Tissue levels of human beta-defensin 1 before and after NB-UVB phototherapy
Time frame: 6 months to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing skin biopsy before and after NB-UVB phototherapy in people with Vitiligo, run by Cairo 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 4 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 6 Feb 2019. 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?
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?
Tissue levels of human beta-defensin 1 before and after NB-UVB phototherapy (time frame: 6 months to 1 year). 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 6 Feb 2019.