Trichoscopy as a Monitoring Tool for Activity and Remission in Pemphigus Vulgaris: A Clinical Study Supported by Immunological Evaluation.

March 3, 2025 updated by: Dina Abd El-nasser Attay, Assiut University
Pemphigus vulgaris (PV) is a potential life-threatening autoimmune bullous disorder presenting with multiple erosions and flaccid blisters that can involve both mucous membrane and skin. The microscopic findings include intraepithelial blisters caused by acantholysis of keratinocytes as the consequence of autoantibody formation. The antibodies are mainly IgG autoantibodies mostly directed against desmoglein 1 and 3 (Dsg 1, 3), which are adhesion molecules expressed on the surface of keratinocytes.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Scalp is a unique location for pemphigus because of the abundance of desmogleins localized in hair follicles. The frequency of scalp involvement in the course of pemphigus is estimated at 16-60% . According to literature data, the scalp is the first location in 9-15% of patients with pemphigus.

Several cases of alopecia in the course of pemphigus have been described. The significance of the distribution of desmogleins in hair follicles for scalp involvement and a potential use of direct immunofluorescence of plucked hairs are discussed in the literature. The significance of scalp involvement for the course of pemphigus remains controversial.

Trichoscopy is a non-invasive method for diagnosing hair and scalp disorders. Trichoscopy is widely used to differentiate causes of scalp lesions and scarring and non-scarring alopecia. To date there are few studies on the value of trichoscopy in pemphigus.

The pathogenesis and pathophysiology of PV depend on various factors like cellular immunity, genetic factors, ethnicity, diet and environment. According to previous studies, Dsg autoantibodies with IgG1 and IgG4 subtypes are mostly detected in the active form of the pemphigus diseases. Accordingly, the significant role of autoreactive B cells in the pathogenesis of PV could be explained by producing these types of autoantibodies.

Recently attention has been directed toward the role of T cells in the pathogenesis of PV. Similar to other autoimmune diseases, the underlying etiology of PV depends on the interaction between T cells and B cells resulting in antibody secretion.

Autoreactive CD4+ T cells are essential for the pathogenesis of several ab-mediated autoimmune diseases by providing help to autoreactive B cells resulting in the production of antigen specific auto-ab. Alterations in several T cell subsets like CD4+CD25+ Treg and Th17 cells, have been described and are suggested to play a role in the pathogenesis of pemphigus.

A few studies have investigated the significant role of T cell subgroups, namely regulatory T cells (Treg), T helper17 (Th17), and T follicular helper cells (Tfh) in PV and some studies were carried out on both human and mouse models to meticulously reveal the function of T cell phenotypes including CD8+T cells, γδ T cells, and resident memory T cells in the pathogenesis of PV, which may explain the wide range of clinical presentations and severity of PV in patients.

Study Type

Observational

Enrollment (Estimated)

62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sara Mohamed Ibrahim Awad, Professor
  • Phone Number: +201023102094
  • Email: saramawad@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients will be recruited from those attending the Bullous outpatient clinic of department of Dermatology, Assiut University Hospitals with the diagnosis of pemphigus vulgaris. Patients will be included in the study after obtaining a written informed consent. And after the approval of the faculty of medicine ethics committee. An age and sex matched healthy volunteers will be recruited as a control group.

Description

Inclusion Criteria:

  • Patients with clinical and histopathological diagnosis of pemphigus vulgaris will be included.
  • Pemphigus patients are categorized as active or remittent.

Exclusion Criteria:

  • Other forms of pemphigus.
  • Patients who are previously treated with rituximab.
  • Patients with any concomitant dermatological diseases.
  • Patients with other autoimmune diseases.
  • Pregnancy and lactation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
cases of PV with disease activity
Diagnostic test: Trichoscopy
Trichoscopy will be done on patients with PV disease activity and remission
Group 2
cases of PV with disease remission
Diagnostic test: Trichoscopy
Trichoscopy will be done on patients with PV disease activity and remission
Group 3
control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trichoscopy as a monitooring tool
Time Frame: 1 year
for activity and remission in PV
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

March 3, 2025

First Submitted That Met QC Criteria

March 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 3, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tricho PV

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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