VitiligoNCT03367273
Thymic Stromal Lymphopoietin (TSLP) in Vitiligo
A study testing skin biopsy in people with Vitiligo, run by Cairo University.
Trial summary
study \& verify the hypothesis of the involvement of TSLP in the pathogenesis of vitiligo in comparison to their levels in the healthy control persons. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jul 2017
- 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 generalized non-segmental vitiligo.
- Both sexes.
- Age < 18 years old age.
- New cases or cases not receiving any medication for at least 3 months ago.
Who cannot join
- • Age: Patients < 18 years.
- Segmental or universal vitiligo.
- Pregnant and lactating females. Autoimmune diseases
About this study
Official title: Study of the Cutaneous Expression of Thymic Stromal Lymphopoietin (TSLP) in a Sample of Vitiligo Patients
study \& verify the hypothesis of the involvement of TSLP in the pathogenesis of vitiligo in comparison to their levels in the healthy control persons.
- Conditions
- Vitiligo
- Being tested
- skin biopsy
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin biopsyOther
Lesional skin biopsy was taken from every patient. Also a skin biopsy was taken from every control subject
| Study group | Role | What they receive |
|---|---|---|
| vitiligo patients | Experimental | Not described Receives: Other: skin biopsy |
| controls | Experimental | Not described Receives: Other: skin biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression levels of TSLP in patients of Vitiligo.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study startJan 2017
- Primary completionJul 2017
- Study completionJul 2017
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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
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
- NCT03367273
- Sponsor's protocol ID
- Dermatology 2
- Status last verified
- Dec 2017
- First submitted
- 5 Dec 2017
- Last updated
- 20 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Cutaneous Expression of Thymic Stromal Lymphopoietin (TSLP) in a Sample of Vitiligo Patients
- ClinicalTrials.gov ID
- NCT03367273
- Acronym / sponsor ID
- Dermatology 2
- Conditions
- Vitiligo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 8 Dec 2017 (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.
study \& verify the hypothesis of the involvement of TSLP in the pathogenesis of vitiligo in comparison to their levels in the healthy control persons.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitiligo patients | Experimental | Other: skin biopsy |
| controls | Experimental | Other: skin biopsy |
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 generalized non-segmental vitiligo.
Key exclusion criteria (3 listed)
- • Age: Patients < 18 years.
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 biopsyLesional skin biopsy was taken from every patient. Also a skin biopsy was taken from every control subject | Other | controls, vitiligo patients |
Primary outcome
Expression levels of TSLP in patients of Vitiligo.
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2017.
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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 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 3 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: finished, as of the sponsor's last update on 20 Dec 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Expression levels of TSLP in patients of Vitiligo. (time frame: 7 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 20 Dec 2017.