Role of Tzanck Smear in Determining Pemphigus Vulgaris Disease Activity

Sponsor

Istanbul Medeniyet University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05338112

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pemphigus Vulgaris	Diagnostic Test: Tzanck smear

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

50 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Evaluation of the Relationship of Tzanck Smear Findings And Disease Activity In Patients With Pemphigus Vulgaris

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Patients with active pemphigus lesions	Diagnostic Test: Tzanck smear 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.

Arm

Intervention/Treatment

Patients with active pemphigus lesions

Diagnostic Test: Tzanck smear

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.

Outcome Measures

Primary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul Medeniyet University	Istanbul		Turkey

Sponsors and Collaborators

Istanbul Medeniyet University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zeynep Arslan, Doctor of Medicine, Istanbul Medeniyet University

ClinicalTrials.gov Identifier:

NCT05338112

Other Study ID Numbers:

10457119

First Posted:

Apr 20, 2022

Last Update Posted:

Aug 2, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Zeynep Arslan, Doctor of Medicine, Istanbul Medeniyet University

pemphigus vulgaris, Tzanck smear, disease activity, prognostic factor

Additional relevant MeSH terms:

Pemphigus

Study Results

No Results Posted as of Aug 2, 2022