ClinicalTrials.gg
Status unknownNCT05338112Updated Mar 1, 2023

Role of Tzanck Smear in Determining Pemphigus Vulgaris Disease Activity

An observational study in Pemphigus Vulgaris, sponsored by Istanbul Medeniyet University. Status unknown at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-01.

Sponsored by Istanbul Medeniyet University · Observational

The sponsor has not verified this record recently (last verified Apr 2022), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Pemphigus Vulgaris

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Keywords

  • pemphigus vulgaris, Tzanck smear, disease activity, prognostic factor
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In context

Pemphigus

76 studies on the registry are indexed under Pemphigus; 18 are open to participants now.

This study's planned enrollment of 50 is below the median of 60 across 21 observational studies indexed under Pemphigus.

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Lead sponsor

Istanbul Medeniyet University is the lead sponsor of 192 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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)
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • Patients with active pemphigus lesions

    Diagnostic Test: Tzanck smear

Interventions

  • Diagnostic testTzanck 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.

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What researchers measure

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).

    Time frame: 1or 2 months

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Study locations

1 site
  • Istanbul Medeniyet University
    Istanbul, Turkey
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References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05338112
Responsible party
Zeynep Arslan (Doctor of Medicine, Istanbul Medeniyet University) — Principal investigator
First posted
Apr 20, 2022
Start date
Jan 1, 2022
Primary completion
Mar 15, 2023 (estimated)
Completion
Apr 15, 2023 (estimated)
Last update
Mar 1, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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