Sensory Symptoms in Active Vitiligo

• Sponsor: Cairo University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05390164
• Collaborator: (none)
• Enrollment: 90
• Anticipated Duration (Months): 2.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Totest Sensory Symptoms in Active Vitiligo	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 Design

• Study Type: Observational
• Anticipated Enrollment: 90 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Sensory Symptoms as an Early Manifestation of Active Vitiligo: a Case-control Clinical and Molecular Study
• Anticipated Study Start Date: May 25, 2022
• Anticipated Primary Completion Date: Aug 15, 2022
• Anticipated Study Completion Date: Aug 15, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Neuropeptide [3 months]

   laboratory test

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Active and stable vitiligo

Exclusion Criteria:

• Diabetic or other associated disease

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: Hagar El Sayed, Dr, Cairo University
• ClinicalTrials.gov Identifier: NCT05390164
• Other Study ID Numbers: Pruritis in vitiligo
• First Posted: May 25, 2022
• Last Update Posted: May 25, 2022
• Last Verified: May 1, 2022

• 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 May 25, 2022