Clinical trial NCT05992727: Evaluation of Galectin-3 in Serum and Saliva of Pemphigus Patients
Official title: Evaluation of Galectin 3 Level in Serum and Saliva of Pemphigus Patients and Its Correlation With Disease Severity and Systemic Comorbidities
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Galectin-3 and Pemphigus
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pemphigus patients in active stage either newly diagnosed or in a relapse. The diagnosis of each patient is based on clinical examination , histopathological examination and direct immunofluorescence.

Brief summary: 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).

Detailed description: Pemphigus is a potentially life- threatening immune mediated bullous disease that affects the skin and mucous membranes with a significant impact on quality of life (1). It is due to production of autoantibodies against desmogleins (adhesion molecules of the epidermis) leading to disruption of junctions between keratinocytes and subsequently acantholysis (2).

Pemphigus diseases are classified based on the clinical, histopathological features, as well as on the specific antigens against which the autoantibodies are produced. The main forms are pemphigus vulgaris (PV) and pemphigus folia¬ceus (PF), but other non-classical forms of pemphigus have also been described as paraneoplastic pemphigus, pemphigus herpetiformis, and IgA pemphigus (3). PV is the main clinical form of pemphigus, accounting for approximately 70% of cases; it is also considered the most severe form of the disease (4).

IgG is the main immunoglobulin seen along the dermal-epidermal junction in pemphigus patients, in addition most patients generate IgE autoantibody response. Soluble CD23 and galectin-3 are the two main elements of the IgE (5).

Galectin-3(Gal-3) is a beta galactoside-binding lectins that is essential in the cell-to-cell or matrix adhesion, as well as plays an important role in cell growth, differentiation, macrophage activation, antimicrobial activity, angiogenesis, and apoptosis. It broadly exists in the nucleus and cytoplasm of various cell types or may be found extracellularly on the cell surface (6) .Gal-3 is readily secreted to the cell surface and into biological fluids as serum, urine, tears and saliva from injured and inflammatory cells. So, it can be used as a sensitive diagnostic or prognostic biomarker for various pathological conditions (7).

Gal-3 has been used as a novel biomarker in the early detection of myocardial dysfunction and heart failure. Many cardiac biomarkers which reflect cardiac inflammation and fibrosis may also contribute to the progression of kidney disease (8, 9) A previous study reported a significant decrease in galectin-3 cytoplasmic and nuclear expression around blisters compared with adjacent unaffected skin in PV, which may play a role in extension of acantholysis (5). To the best of our knowledge, no previous studies assessed the role of Gal-3 in serum or saliva of pemphigus patients.

Eligibility criteria: Inclusion Criteria:

Patients with active stage of pemphigus.

Exclusion Criteria:

1. Patients who were on topical ttt, systemic corticosteroids or other immunosuppressive drugs in the last one month.
2. Patients with disease attack duration more than 1 week.
3. Patients with any other concomitant dermatological or chronic systemic diseases.

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Primary outcomes:
measure: Assessment of Galectin 3
timeFrame: 1 year
measure: Develop a novel biomarker in serum and saliva of pemphigus patients and to detect its correlation with disease activity, as well as systemic comorbidities.
timeFrame: 1year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Aghighi M, Pukhalskaya T, Smoller BR. Immunohistochemical Expression of Galectin-3 in Pemphigus Vulgaris. Am J Dermatopathol. 2021 Dec 1;43(12):e165-e168. doi: 10.1097/DAD.0000000000001939.