Verruca VulgarisNCT05409365
Assessment of Squamous Cell Carcinoma antigen2 in Verruca Vulgaris
An observational study of Verruca Vulgaris and Healthy, run by Sohag University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Verruca Vulgaris, Healthy
- What is being tested?
- Immunohistochemical staining monoclonal antibodies to SCCA2 (SERPINB4/ SCCA2 antibody)
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 1 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: primary care clinic
Who may be able to join
- Patients present with warts (verruca vulgaris type).
Who cannot join
- Subjects who presenting with allergic diseases or other dermatological diseases or had a history of squamous cell carcinoma will be excluded from this study.
Trial locations and contacts
1 site in 1 country.
Ashraf Ahmed Abd El-Latif Abd El-Latif, Lecturer contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University
Sohag
Fatma Abo-Elmagd Abd-Elgaber, Resident, 01021708589, fatma011124@med.sohag.edu.eg
About this study
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.
- Conditions
- Verruca Vulgaris, Healthy
- Being tested
- Immunohistochemical staining monoclonal antibodies to SCCA2 (SERPINB4/ SCCA2 antibody)
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunohistochemical staining monoclonal antibodies to SCCA2 (SERPINB4/ SCCA2 antibody)Other
Immunohistochemical staining
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start1 May 2022
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Verruca VulgarisStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Aboelmaged Abdelgaber, Sohag University
- Investigators
- Ashraf Ahmed Abd El-Latif Abd El-Latif, Lecturer, Study director, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409365
- Sponsor's protocol ID
- Soh-Med-22-04-07
- Status last verified
- Jun 2022
- First submitted
- 1 Jun 2022
- Last updated
- 10 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Squamous Cell Carcinoma antigen2 in Verruca Vulgaris
- ClinicalTrials.gov ID
- NCT05409365
- Acronym / sponsor ID
- Soh-Med-22-04-07
- Conditions
- Verruca Vulgaris, Healthy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (1 listed)
- Patients present with warts (verruca vulgaris type).
Key exclusion criteria (1 listed)
- Subjects who presenting with allergic diseases or other dermatological diseases or had a history of squamous cell carcinoma will be excluded from this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunohistochemical staining monoclonal antibodies to SCCA2 (SERPINB4/ SCCA2 antibody)Immunohistochemical staining | Other | – |
Primary outcome
Assessment of Squamous Cell Carcinoma Antigen2 in Verruca Vulgaris
Time frame: through study completion, an average of 1 year
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Verruca Vulgaris
Active, not recruitingPhase 3
Cantharidin Application in Patients With Common Warts (Verruca Vulgaris) (COVE-2)
Common Warts, Common Warts (Verruca Vulgaris)
RecruitingPhase 3
Long-Term Follow-up Study of Cantharidin (YCANTH [VP-102/TO-208]) in Patients With Common Warts (Verruca Vulgaris)
Common Warts (Verruca Vulgaris), Common Warts
Not yet recruitingPhase 2
Safety and Systemic Exposure of YCANTH (VP-102) in Subjects With Common Warts (Verruca Vulgaris) (COVE-5)
Common Warts, Common Warts (Verruca Vulgaris)
Active, not recruitingPhase 2
Intralesional Gardasil-9 for the Treatment of Recalcitrant Warts
Warts, Verruca (Warts)
RecruitingPhase 3
Cantharidin Application in Patients With Common Warts (Verruca Vulgaris) (COVE-3)
Common Warts, Common Warts (Verruca Vulgaris)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashraf Ahmed Abd El-Latif Abd El-Latif, Lecturer contact
Ashraf Ahmed Abd El-Latif Abd El-Latif, Lecturer study director
Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Verruca Vulgaris and Healthy, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatma Aboelmgd Abd-Elgaber, Resident (01021708589, fatma011124@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Squamous Cell Carcinoma Antigen2 in Verruca Vulgaris (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2022.