Role of Tzanck Smear in Determining Pemphigus Vulgaris Disease Activity

• Conditions: Pemphigus Vulgaris
• Interventions: Diagnostic Test: Tzanck smear

• Registration Number: NCT05338112
• Lead Sponsor: Istanbul Medeniyet University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2022-04
• Study First Submitted: 2022-04-07
• Study First Submitted QC: 2022-04-13
• Study First Posted: 2022-04-20
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-01
• Primary Completion: 2023-03-15
• Study Completion: 2023-04-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

• 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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with active pemphigus lesions	Tzanck smear	-

Primary Outcome Measures

Name	Time	Method
The number of acantholytic cells	1or 2 months	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).

Trial Locations

Locations (1)

Istanbul Medeniyet University; 🇹🇷 Istanbul, Turkey