CClinicalTrials.gg
Status unknownNCT05409365Updated Jun 10, 2022

Assessment of Squamous Cell Carcinoma antigen2 in Verruca Vulgaris

An observational study in Verruca Vulgaris and Healthy, sponsored by Sohag University. Status unknown at 1 site in Egypt. Open to participants aged 1 Year and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-10.

Sponsored by Sohag University · Observational

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
50
Ages
1 Year and older
Sex
All
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Study summary

This study aims to assess the expression of SCCA2 in the skin of patients with warts and to detect its correlation with characteristics of warts.

Read the detailed description

Type of the study: Cross sectional study. Patients: This study will include 25 patients with verruca vulgaris and 25 healthy volunteers.

Inclusion criteria:

Patients present with warts (verruca vulgaris type).

Exclusion criteria:

Subjects who presenting with allergic diseases or other dermatological diseases or had a history of squamous cell carcinoma will be excluded from this study One skin biopsy will be taken from each healthy volunteers of the control group via 2-mm disposable punches under complete sterile precautions. Two biopsies will be taken from patients with wart lesion one from verruca vulgaris via 5-mm disposable punches and another from non-affected skin via 2-mm disposable punches under complete sterile precautions.

Biopsy handling: Each specimen in both groups will be fixed in formalin and embedded in paraffin to form paraffin blocks. Serial sections will be obtained from each block and stained with hematoxylin and eosin (H\&E) for histological diagnosis.

Stained sections will be examined under a light microscope. To confirm the diagnosis of wart, the grade of inflammation and the density of dermal inflammatory infiltrate will be classified as follows Grade 0, no infiltrate; Grade 1, mild; Grade 2, moderate; or Grade 3, marked infiltrate.

Immunohistochemical staining: investigators will use monoclonal antibodies to SCCA2 (SERPINB4/ SCCA2 antibody). Immunohistochemical staining will be performed the pattern of immunostaining for SCCA2 will be evaluated in both the epidermis and dermis of wart lesions. The immunohistochemical score (IHC) range will be as follows: 0: negative expression of SCCA2; 1+: weak expression of SCCA2; 2+: moderate expression of SCCA2; and 3+: strong expression of SCCA2.

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Conditions studied

  • Verruca Vulgaris
  • Healthy
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In context

Warts

180 studies on the registry are indexed under Warts; 28 are open to participants now.

This study's planned enrollment of 50 is below the median of 153 across 16 observational studies indexed under Warts.

Browse Warts studies →

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

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

04

Who can participate

Ages eligible
1 Year and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

primary care clinic

Inclusion criteria

  • Patients present with warts (verruca vulgaris type).

Exclusion criteria

Exclusion Criteria:

  • Subjects who presenting with allergic diseases or other dermatological diseases or had a history of squamous cell carcinoma will be excluded from this study.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
50 participants (estimated)
Patient registry
No

Interventions

  • OtherImmunohistochemical staining monoclonal antibodies to SCCA2 (SERPINB4/ SCCA2 antibody)

    Immunohistochemical staining

06

What researchers measure

Primary outcomes

  1. Assessment of Squamous Cell Carcinoma Antigen2 in Verruca Vulgaris

    Immunohistochemical staining: investigators will use monoclonal antibodies to SCCA2 (SERPINB4/ SCCA2 antibody). Immunohistochemical staining will be performed the pattern of immunostaining for SCCA2 will be evaluated in both the epidermis and dermis of wart lesions. The immunohistochemical score (IHC) range will be as follows: 0: negative expression of SCCA2; 1+: weak expression of SCCA2; 2+: moderate expression of SCCA2; and 3+: strong expression of SCCA2.

    Time frame: through study completion, an average of 1 year

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05409365
Lead sponsor
Sohag University
Responsible party
Fatma Aboelmaged Abdelgaber (Resident of Dermatology and Venereology, Sohag University) — Principal investigator
First posted
Jun 8, 2022
Start date
May 1, 2022
Primary completion
Nov 1, 2022 (estimated)
Completion
Jan 1, 2023 (estimated)
Last update
Jun 10, 2022

Study contacts

Fatma Aboelmgd Abd-Elgaber, Resident
Contact
fatma011124@med.sohag.edu.eg
01021708589
Ashraf Ahmed Abd El-Latif Abd El-Latif, Lecturer
Contact
01021889811
Ashraf Ahmed Abd El-Latif Abd El-Latif, Lecturer
study director · Director

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 Jun 2022. You cannot join it, but the record below documents what was studied.

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