VitiligoNCT05812079
Insulin Like Growth Factor-1 Against Oxidative Stress in Vitiligo
An observational study of Vitiligo, run by Cairo University.
Trial summary
Insulin like growth factor has a protective role on melanocytes against the oxidative stress. The aim is to investigate this effect in vitiligo patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- skin biopsy examined by ELISA technique
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 1 Oct 2024
- Phase
- Observational
- 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
- Adult
Study population: Non-Segmental Vitiligo
Who may be able to join
- Non-segmental vitiligo
Who cannot join
- Pregnant or lactating females
- Smokers
- Patients with any endocrinal disease known to affect GH or IGF-1 as Diabetes (by measuring HbA1c) and Thyroid disturbance (by measuring TSH)
- Patients with liver disease (by measuring AST, ALT and GGT)
- Obese patients (by measuring BMI)
- Patients with history of ischemic heart disease (known medical history of angina or myocardial infarction or history of recurrent chest pain, left shoulder pain, shortness of breath or fatigue on the ordinary effort or less than the ordinary effort )
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- Patients with history of Peripheral arterial disease (Known medical history of peripheral arterial thrombosis or history of recurrent claudications)
- Patients with history of cerebero-vascular disease (known medical history of transient ischemic attacks or stroke)
- Patients who received systemic treatment for vitiligo during the previous six months or topical treatment during the previous two months
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessing the Protective Role of Insulin Like Growth Factor 1 Against Oxidative Stress in Vitiligo Patients
Insulin like growth factor has a protective role on melanocytes against the oxidative stress. The aim is to investigate this effect in vitiligo patients.
- Conditions
- Vitiligo
- Being tested
- skin biopsy examined by ELISA technique
- 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 examined by ELISA techniqueDiagnostic test
skin biopsy examined by ELISA technique
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate for IGF-1 and IMA levels in vitiligo
To measure the level of IGF-1 and the level of IMA in perilesional and distant skin of vitiligo patients and compare these levels with normal controls to investigate the relationship between IGF-1, as a protective from oxidative stress and IMA, as a marker of oxidative stress in vitiligo.
Measured: one year
Secondary outcomes (1)
Measure IMA in vitiligo and correlate it with psychological status of patients
To measure the serum level of IMA as a marker of oxidative stress in vitiligo patients versus normal controls 2- To correlate the findings with the VIS-22 score
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start1 Feb 2024 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Salah El-Din El-Mesidy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812079
- Sponsor's protocol ID
- IGF-1 in Vitilgo
- Status last verified
- Feb 2024
- First submitted
- 31 Mar 2023
- Last updated
- 8 Feb 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 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Protective Role of Insulin Like Growth Factor 1 Against Oxidative Stress in Vitiligo Patients
- ClinicalTrials.gov ID
- NCT05812079
- Acronym / sponsor ID
- IGF-1 in Vitilgo
- Conditions
- Vitiligo
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 13 Apr 2023 (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.
Insulin like growth factor has a protective role on melanocytes against the oxidative stress. The aim is to investigate this effect in vitiligo patients.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Non-Segmental Vitiligo
Key inclusion criteria (1 listed)
- Non-segmental vitiligo
Key exclusion criteria (9 listed)
- Pregnant or lactating females
- Smokers
- Patients with any endocrinal disease known to affect GH or IGF-1 as Diabetes (by measuring HbA1c) and Thyroid disturbance (by measuring TSH)
- Patients with liver disease (by measuring AST, ALT and GGT)
- Obese patients (by measuring BMI)
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 examined by ELISA techniqueskin biopsy examined by ELISA technique | Diagnostic test | – |
Primary outcome
Investigate for IGF-1 and IMA levels in vitiligo
Time frame: one year
To measure the level of IGF-1 and the level of IMA in perilesional and distant skin of vitiligo patients and compare these levels with normal controls to investigate the relationship between IGF-1, as a protective from oxidative stress and IMA, as a marker of oxidative stress in vitiligo.
1 secondary outcome
Measure IMA in vitiligo and correlate it with psychological status of patients
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 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?
An observational study of 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 1 inclusion and 9 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 8 Feb 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 Marwa El-Mesidy, MD (01005139967, marwa.elmesidy@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigate for IGF-1 and IMA levels in vitiligo (time frame: one 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 8 Feb 2024.