Sensory Symptoms in Active Vitiligo

Sensory Symptoms as an Early Manifestation of Active Vitiligo: a Case-control Clinical and Molecular Study

This work aims to assess sensory symptoms in early active vitiligo patients (segmental, non-segmental, or mixed) and to measure 3 neuropeptides expression in their lesional skin [neuropeptide Y(NPY), calcitonin gene-related peptide (CGRP), and nerve growth factors (NGF)] to correlate neuropeptide levels, sensory symptoms, and functions, with criteria of disease activity and perceived stress scale.

Study Overview

• Status: Not yet recruiting
• Conditions: Totest Sensory Symptoms in Active Vitiligo
• Intervention / Treatment: Diagnostic test: skin biopsy

Detailed Description

Study Design: Case-control study Population: 45 patients with active vitiligo and 45 patients with stable vitiligo

Inclusion criteria:

Age: 18 years old and older Sex: both sexes

Exclusion criteria:

Other hypopigmented diseases such as pityriasis alba, tinea versicolor, lichen sclerosis, post-inflammatory hyperpigmentation, and leprosy as excluded by lack of accentuation by wood's light examination. - Cases who received treatment (systemic or topical) in the last 3 months before sampling. - Neurological or other diseases that cause itching. - Medical history of DM, HTN, or other systemic diseases, history of associated autoimmune diseases.

Assessment will be carried as follows: • History of itching or other abnormal neurological sensations as paresthesia and numbness. Aggravating factors (e.g. dryness, hot environment, sun exposure, ..etc), alleviating factors of itching Type of vitiligo (segmental, unilateral, vulgaris). • Assessment of activity by assessing: koebner's phenomenon, confetti depigmentation, trihypochrome areas, poorly defined borders, inflammatory signs (e.g eye inflammation and hearing loss), and leukotrichia. • Assessment of sensory symptoms and signs (fine touch, crude touch, pain, and sweating by starch iodine test) in active vitiliginous patches. • Clinical assessment: the vitiligo area score index (VASI), vitiligo extent scores (VES), vitiligo disease activity score (VIDA) (Feily, 2014) will be assessed in every participant and demographic data

• Study Type: Observational
• Enrollment (Anticipated): 90

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Active vitiligo patients

Description

Inclusion Criteria:

• Active and stable vitiligo

Exclusion Criteria:

• Diabetic or other associated disease

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Active vitiligo	Diagnostic test: skin biopsy; skin biopsy to be analyzed by ELISA
Stable vitiligo	Diagnostic test: skin biopsy; skin biopsy to be analyzed by ELISA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuropeptide	laboratory test	3 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 25, 2022
• Primary Completion (Anticipated): August 15, 2022
• Study Completion (Anticipated): August 15, 2022

Study Registration Dates

• First Submitted: May 20, 2022
• First Submitted That Met QC Criteria: May 20, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Actual): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 20, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation; Vitiligo
• Other Study ID Numbers: Pruritis in vitiligo

Drug and device information, study documents

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