Insulin Like Growth Factor-1 Against Oxidative Stress in Vitiligo

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vitiligo
• Intervention / Treatment: Diagnostic test: skin biopsy examined by ELISA technique

• Study Type: Observational
• Enrollment (Estimated): 33

Contacts and Locations

• Study Contact: Name: Marwa El-Mesidy, MD; Phone Number: 01005139967; Email: marwa.elmesidy@kasralainy.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Non-Segmental Vitiligo

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	One year

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: March 31, 2023
• First Submitted That Met QC Criteria: March 31, 2023
• First Posted (Actual): April 13, 2023

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation; Vitiligo
• Other Study ID Numbers: IGF-1 in Vitilgo

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No