Role of Tzanck Smear in Determining Pemphigus Vulgaris Disease Activity

NCT05338112 | Unknown

• 1 other identifier: 10457119
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pemphigus Vulgaris

Keywords

pemphigus vulgaris, Tzanck smear, disease activity, prognostic factor

Outcome Measures

Primary Outcomes (1)

• The number of acantholytic cells

  Tzanck smear slides will be entirely scanned, acantholytic cell count will be 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).

  1or 2 months

Study Arms (1)

Patients with active pemphigus lesions

Diagnostic Test: Tzanck smear

Interventions

Tzanck smear DIAGNOSTIC_TEST

The Tzanck smear is gently taken with a sterile scalpel from the ground of erosion or bullous lesions of pemphigus vulgaris. The sample taken is examined by staining the slide.

Patients with active pemphigus lesions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who were diagnosed with pemphigus vulgaris by clinical, histopathological and immunological methods.

You may qualify if:

• Clinical, histopathological and immunological diagnosis of pemphigus vulgaris
• Must be active bullae or erosion at any stage of the disease

You may not qualify if:

• Patients with uncertain diagnosis of pemphigus vulgaris
• Eroded lesions due to causes other than pemphigus vulgaris (such as herpes in the oral mucosa, candida infection)

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Istanbul Medeniyet University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pemphigus

Condition Hierarchy (Ancestors)

Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Medicine

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 20, 2022
• Study Start: January 1, 2022
• Primary Completion: March 15, 2023
• Study Completion: April 15, 2023
• Last Updated: March 1, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)