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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05338112
Other study ID # 10457119
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date April 15, 2023

Study information

Verified date April 2022
Source Istanbul Medeniyet University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 50
Est. completion date April 15, 2023
Est. primary completion date March 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Turkey Istanbul Medeniyet University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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