Assessment of Squamous Cell Carcinoma antigen2 in Verruca Vulgaris

Healthy Clinical Trial

Official title:

Assessment of Squamous Cell Carcinoma antigen2 in Verruca Vulgaris

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05409365
• Other study ID #: Soh-Med-22-04-07
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: January 1, 2023

Study information

• Verified date: June 2022
• Source: Sohag University
• Contact: Fatma Aboelmgd Abd-Elgaber, Resident
• Phone: 01021708589
• Email: fatma011124[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 1, 2023
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Healthy
• Verruca Vulgaris
• Warts

Intervention

Other:
• Immunohistochemical staining monoclonal antibodies to SCCA2 (SERPINB4/ SCCA2 antibody)
Immunohistochemical staining

Locations

Country	Name	City	State
Egypt	Sohag University	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion, an average of 1 year