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Not yet recruiting NCT06863454

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

— Observational Pemphigus Vulgaris (PV)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Trichoscopy.
Who it may be relevant to
Registry conditions: Pemphigus Vulgaris (PV). Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Interventions

  • Diagnostic test Trichoscopy
    Trichoscopy will be done on patients with PV disease activity and remission

Primary outcome measures

  • Trichoscopy as a monitooring tool [Time frame: 1 year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Xu RC, Zhu HQ, Li WP, Zhao XQ, Yuan HJ, Zheng J, Pan M. The imbalance of Th17 and regulatory T cells in pemphigus patients. Eur J Dermatol. 2013 Nov-Dec;23(6):795-802. doi: 10.1684/ejd.2013.2177. PMID 24192290
  • Wu H, Stanley JR, Cotsarelis G. Desmoglein isotype expression in the hair follicle and its cysts correlates with type of keratinization and degree of differentiation. J Invest Dermatol. 2003 Jun;120(6):1052-7. doi: 10.1046/j.1523-1747.2003.12234.x. PMID 12787134
  • Veraitch O, Ohyama M, Yamagami J, Amagai M. Alopecia as a rare but distinct manifestation of pemphigus vulgaris. J Eur Acad Dermatol Venereol. 2013 Jan;27(1):86-91. doi: 10.1111/j.1468-3083.2011.04363.x. Epub 2011 Nov 28. PMID 22122058
  • Tavakolpour S, Mahmoudi H, Mirzazadeh A, Balighi K, Darabi-Monadi S, Hatami S, GhasemiAdl M, Daneshpazhooh M. Pathogenic and protective roles of cytokines in pemphigus: A systematic review. Cytokine. 2020 May;129:155026. doi: 10.1016/j.cyto.2020.155026. Epub 2020 Feb 10. PMID 32058276
  • Takahashi H, Amagai M, Nishikawa T, Fujii Y, Kawakami Y, Kuwana M. Novel system evaluating in vivo pathogenicity of desmoglein 3-reactive T cell clones using murine pemphigus vulgaris. J Immunol. 2008 Jul 15;181(2):1526-35. doi: 10.4049/jimmunol.181.2.1526. PMID 18606708
  • Sar-Pomian M, Rudnicka L, Olszewska M. The Significance of Scalp Involvement in Pemphigus: A Literature Review. Biomed Res Int. 2018 Mar 25;2018:6154397. doi: 10.1155/2018/6154397. eCollection 2018. PMID 29770335
  • Sar-Pomian M, Rudnicka L, Olszewska M. Trichoscopy - a useful tool in the preliminary differential diagnosis of autoimmune bullous diseases. Int J Dermatol. 2017 Oct;56(10):996-1002. doi: 10.1111/ijd.13725. Epub 2017 Aug 30. PMID 28856676
  • Sar-Pomian M, Kurzeja M, Rudnicka L, Olszewska M. The value of trichoscopy in the differential diagnosis of scalp lesions in pemphigus vulgaris and pemphigus foliaceus. An Bras Dermatol. 2014 Nov-Dec;89(6):1007-12. doi: 10.1590/abd1806-4841.20143830. PMID 25387515

Identifiers

NCT: NCT06863454 · Tricho PV

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗