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Insulin Like Growth Factor-1 Against Oxidative Stress in Vitiligo

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05812079
Collaborator
(none)
33
Enrollment
13
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: skin biopsy examined by ELISA technique

Study Design

Study Type:
Observational
Anticipated Enrollment :
33 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Assessing the Protective Role of Insulin Like Growth Factor 1 Against Oxidative Stress in Vitiligo Patients
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Investigate for IGF-1 and IMA levels in vitiligo [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.

Secondary Outcome Measures

  1. Measure IMA in vitiligo and correlate it with psychological status of patients [One year]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Non-segmental vitiligo
Exclusion Criteria:

  1. Pregnant or lactating females

  2. Smokers

  3. Patients with any endocrinal disease known to affect GH or IGF-1 as Diabetes (by measuring HbA1c) and Thyroid disturbance (by measuring TSH)

  4. Patients with liver disease (by measuring AST, ALT and GGT)

  5. Obese patients (by measuring BMI)

  6. 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 )

  7. Patients with history of Peripheral arterial disease (Known medical history of peripheral arterial thrombosis or history of recurrent claudications)

  8. Patients with history of cerebero-vascular disease (known medical history of transient ischemic attacks or stroke)

  9. Patients who received systemic treatment for vitiligo during the previous six months or topical treatment during the previous two months

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marwa Salah El-Din El-Mesidy, Associate Professor, Cairo University
ClinicalTrials.gov Identifier:
NCT05812079
Other Study ID Numbers:
  • IGF-1 in Vitilgo
First Posted:
Apr 13, 2023
Last Update Posted:
Apr 18, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Vitiligo

Study Results

No Results Posted as of Apr 18, 2023