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Pemphigus clinical trials

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NCT ID: NCT06285435 Not yet recruiting - Pemphigus Clinical Trials

Coagulation Activation in Patients With Pemphigus

Start date: March 1, 2024
Phase:
Study type: Observational

Aim of work: 1. To evaluate the plasma markers of coagulation activation: prothrombin F1+2 and d-dimer levels in pemphigus patients with active disease and compare them with age and sex-matched controls. 2. To evaluate the correlation of these markers with disease severity score by using Pemphigus Disease Area Index (PDAI) and with disease activity by measurement of anti-desmoglein 1 and 3 antibody titers.

NCT ID: NCT06167408 Completed - Pemphigus Vulgaris Clinical Trials

Identifying Factors Influencing In-Hospital Relapse in Pemphigus Patients

Start date: January 1, 2022
Phase:
Study type: Observational

The objective of this retrospective study was to investigate the factors influencing in-hospital relapse during acute episodes of pemphigus, an autoimmune blistering disease characterized by self-antibodies targeting desmogleins. The study included 96 pemphigus patients hospitalized in China between January 2014 and December 2020. The primary questions addressed by the study were: What are the risk factors associated with in-hospital relapse during acute episodes of pemphigus? Participants in the study underwent a retrospective analysis using univariate and multivariate Cox regression analysis to identify and understand the various risk factors contributing to in-hospital relapse. This research aimed to contribute valuable insights into the factors influencing the course of pemphigus, providing crucial information for better management and treatment strategies.

NCT ID: NCT05992727 Not yet recruiting - Clinical trials for Galectin-3 and Pemphigus

Evaluation of Galectin-3 in Serum and Saliva of Pemphigus Patients

Start date: August 8, 2023
Phase:
Study type: Observational

Assessment of the expression of galectin-3 in serum and saliva of pemphigus patients and compare it with age and sex matched controls. We want to detect whether a correlation exists between galectin-3 level in serum, as well as saliva and disease activity score by Autoimmune Bullous Skin Disorder Intensity Score (ABSIS).

NCT ID: NCT05954416 Recruiting - Clinical trials for Neurofibromatosis Type 1

FARD (RaDiCo Cohort) (RaDiCo-FARD)

FARD
Start date: March 7, 2018
Phase:
Study type: Observational

The goal of this observational study is to conduct a prospective assessment of the individual Burden of 9 rare skin diseases to assess disability in the broadest sense of the term (psychological, social, economic and physical) for patients and/or families. Two types of indicators will be used to reach this objective : 1. an individual burden score calculated based on a burden questionnaire created specifically, approved and designed to understand the tendency to changes in care and lifestyles. The burden questionnaire should be used by patients and/or their family themselves in self-assessment. 2. a descriptive analysis of all resources (medical and non-medical) used by the family unit to manage the disease.

NCT ID: NCT05898308 Not yet recruiting - Pemphigus Clinical Trials

Comparison of a Personalized Maintenance Therapy With the Standard Treatment in Pemphigus

RITUX4
Start date: September 1, 2023
Phase: Phase 4
Study type: Interventional

Pemphigus diseases are life-threatening chronic autoimmune blistering diseases characterized by split formation within the epidermis and surface-close epithelia accompanied by acantholysis. Autoantibodies (Abs) are mainly directed against two structural proteins of the epidermal/epithelial desmosome, desmoglein (Dsg) 1 and Dsg3. Two main pemphigus variants can be differentiated, pemphigus vulgaris (PV), and pemphigus foliaceus (PF). Diagnosis of PV and PF is based on the combination of the clinical picture, histological picture of acantholysis, direct immunofluorescence microscopy (DIF) of a perilesional biopsy and serology. The present "Ritux 4" trial is the fourth academic study with the French study group on auto immune bullous skin diseases (Groupe Bulle) to assess the use of rituximab in auto immune bullous skin diseases, in particular pemphigus. The 3 previous trials have been published in outstanding Journals (N Engl J Med 2007, Science Transl Med 2013, The Lancet 2017 and 2020), and have led to the approval of rituximab in pemphigus by the FDA in 2018 and EMA in 2019. In addition, an industry-sponsored trial testing rituximab versus mycophenolate mofetil in pemphigus, that the investigators have largely contributed to design has been very recently accepted for publication in the N Engl J Med (2021). The investigator hypothesize that a maintenance therapy using an infusion of 1g of rituximab at Month 6 in patients whose anti-Dsg Abs have not sufficiently decreased at Month 3 after the initial cycle of rituximab (persistence of anti-Dsg1 Abs> 20 UI/ml and/or anti-Dsg3 Abs> 130 UI/ml), and or had an initial PDAI score >45 ( first year of follow-up), and the re-treatment with 1g of rituximab of patients whose anti Dsg Abs re-increase during the evolution of pemphigus after the initial cycle of rituximab (anti-Dsg1 Abs> 20 IU/ml, anti-Dsg3 Abs> 50 UI/ml), could be effective in preventing the occurrence of relapses, thus avoiding to restart a CS treatment, and would provide benefit as compared with the current treatment strategy of retreating patients with 2 g of rituximab (1g at Day0 and Day14) combined with oral CS patients, once a clinical relapse occurs.

NCT ID: NCT05635266 Recruiting - Stroke Clinical Trials

A Single-Site Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives

Start date: October 26, 2021
Phase:
Study type: Observational

To collect, preserve, and/or distribute annotated biospecimens and associated medical data to institutionally approved, investigator-directed biomedical research to discover and develop new treatments, diagnostics, and preventative methods for specific and complex conditions.

NCT ID: NCT05594472 Recruiting - Bullous Pemphigoid Clinical Trials

Ozonated Olive Oil in Treatment of Pemphigus Vulgaris and Bullous Pemphigoid

Start date: November 1, 2022
Phase: Phase 3
Study type: Interventional

This study assesses the disinfectant and healing promoting effect of ozonated olive oil in treatment of pemphigus vulgaris and bullous pemphigoid in comparison to conventional topical treatment with topical antibiotic.

NCT ID: NCT05534776 Recruiting - Pemphigus Clinical Trials

Validation of 5-Point Investigator Global Assessments for Pemphigus

Start date: September 21, 2022
Phase:
Study type: Observational

This study aims to explore the reliability and validity of newly developed Investigator Global Assessments (IGAs) in scoring the severity of pemphigus. IGAs are simple 5-point scales ranging from clear - severe and are preferred by the FDA as endpoints in clinical trials.

NCT ID: NCT05338112 Active, not recruiting - Pemphigus Vulgaris Clinical Trials

Role of Tzanck Smear in Determining Pemphigus Vulgaris Disease Activity

Start date: January 1, 2022
Phase:
Study type: Observational [Patient Registry]

Aim: Pemphigus vulgaris (PV) is a rare, life-threatening autoimmune bullous disease that can involve the skin and mucous membranes, characterized by intraepidermal bullae and eroded lesions caused by rupture of the bullae. The aim of this study is to research the relationship of the findings obtained with Tzanck smear, which is an inexpensive and easy method, with disease activity and its prognostic importance in the clinical course in PV patients. Material and Methods: Pemphigus patients who visited to Goztepe Prof. Dr. Suleyman Yalcın City Hospital, Dermatology Clinic will be included in our study. Pemphigus disease area index (PDAI), Tzanck smear findings from the lesions and desmoglein levels during routine follow-up of patients with pemphigus vesicle/bulla/erosion will be evaluated. In the evaluation of Tzanck smear preparations, the entire slide will be scanned, acantholytic cell count performed and scored 1 to 4 accordingly (1 point: 1-3 cells, 2 points: 4-10 cells, 3 points:11-20, 4 points: >21 cells or cell clusters). Anti-desmoglein antibody levels will be analyzed by using enzyme-linked immunosorbent assay (ELISA) method.

NCT ID: NCT05303272 Recruiting - Pemphigus Vulgaris Clinical Trials

A Study to Evaluate Efficacy and Safety of Abatacept in Participants of Pemphigus Vulgaris (PV)

Start date: February 1, 2021
Phase: Phase 4
Study type: Interventional

Pemphigus vulgaris (PV) is a rare, chronic, debilitating, and potentially life-threatening autoimmune disorder that is characterized by mucocutaneous blisters.Abatacept is a biologic drug that belongs to the class of T-cell co-stimulation modulators and is used for the treatment of autoimmune diseases.