WartsNCT06833164
ERAP1,2 in Recalcitrant Warts
An observational study of Warts, run by Benha University at 1 site in Egypt.
Trial summary
The exact mechanisms underlying the contribution of cellular immunity in the eradication of human papillomavirus (HPV) infections remain obscure. Individuals who have treatment-resistant warts frequently have immune deficiencies. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Warts
- What is being tested?
- endoplasmic reticulum Aminopeptidase 1 and 2 and endoplasmic reticulum aminopeptidase 1 and 2 serum levels determination via ELISA
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to 20 Mar 2024
- How long will I take part?
- 1 Day
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Two hundred individuals were separated into two groups. Group (I) patients with resistant warts (n=100), and group (II) age- and sex-matched subjects with history of treated warts with no recurrence (n=100). They were recruited from the Dermatology Outpatient Clinic at Benha University Hospitals
Who may be able to join
- Patients who had a history of incomplete clearance or recurrence following two or more electrocautery sessions and four or more cryocautery treatments and intralesional bleomycin.
Who cannot join
- Patients with genital warts
- Patients on systemic steroids or other immunosuppressive treatments
- Immunocompromised individuals
- Patients suffering from chronic systemic diseases
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Egypt1 site
faculty of medicine Benha University
Banhā, Qalyubia Governorate, 13511
About this study
Official title: Serum ERAP1 and ERAP2 Levels in Patients With Recalcitrant Warts
The exact mechanisms underlying the contribution of cellular immunity in the eradication of human papillomavirus (HPV) infections remain obscure. Individuals who have treatment-resistant warts frequently have immune deficiencies. Amino-peptidases (ERAP1, ERAP2) of endoplasmic reticulum are essential for production of antigenic epitopes that attach to the Major Histocompatibility Complex (MHC) class I and activate T-lymphocytes or natural killer (NK) cells. Aim: To assess ERAP1 and ERAP2 serum concentrations in patients with resistant warts.
- Conditions
- Warts
- Being tested
- endoplasmic reticulum Aminopeptidase 1 and 2, endoplasmic reticulum aminopeptidase 1 and 2 serum levels determination via ELISA
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoplasmic reticulum Aminopeptidase 1 and 2Diagnostic test
endoplasmic reticulum aminopeptidase1 and 2 serum levels determination via ELISA
endoplasmic reticulum aminopeptidase 1 and 2 serum levels determination via ELISADiagnostic test
Also called SEUM ERAP1 MEASUREMENT USING ELISA, SERUM ERAP2MEASUREMENT USING ELISA
endoplasmic reticulum aminopeptidase 1 and 2 serum levels determination via ELISA
What is being measured
The primary outcome is the main question the study is designed to answer.
SERUM LEVELS OF endoplasmic reticulum aminopeptidase 1 and 2
using specific Commercial human ELISA kits
Measured: ONE YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start1 Oct 2022
- Primary completion20 Mar 2024
- Study completion20 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WartsStudies of the same condition, open and under way.
- 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
- 200 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, karem Taha ibrahim khalil, Benha University
- Investigators
- Ihab Y. Abdallah, MD, Study chair, Professor of Dermatology, Venereology and Andrology, Faculty of Medicine, Benha UniversityNehad A.Fouad, MD, Study director, Professor of Microbiology and Immunology, Faculty of Medicine, Benha UniversityOla S Ebrahim, MBBCh, Principal investigator, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06833164
- Sponsor's protocol ID
- Serum ERAP1 and 2 in warts
- Status last verified
- Feb 2025
- First submitted
- 13 Feb 2025
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- 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 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum ERAP1 and ERAP2 Levels in Patients With Recalcitrant Warts
- ClinicalTrials.gov ID
- NCT06833164
- Acronym / sponsor ID
- Serum ERAP1 and 2 in warts
- Conditions
- Warts
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 18 Feb 2025 (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.
The exact mechanisms underlying the contribution of cellular immunity in the eradication of human papillomavirus (HPV) infections remain obscure. Individuals who have treatment-resistant warts frequently have immune deficiencies. Amino-peptidases (ERAP1, ERAP2) of endoplasmic reticulum are essential for production of antigenic epitopes that attach to the Major Histocompatibility Complex (MHC) class I and activate T-lymphocytes or natural killer (NK) cells. Aim: To assess ERAP1 and ERAP2 serum concentrations in patients with resistant warts.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Two hundred individuals were separated into two groups. Group (I) patients with resistant warts (n=100), and group (II) age- and sex-matched subjects with history of treated warts with no recurrence (n=100). They were recruited from the Dermatology Outpatient Clinic at Benha University Hospitals
Key inclusion criteria (1 listed)
- Patients who had a history of incomplete clearance or recurrence following two or more electrocautery sessions and four or more cryocautery treatments and intralesional bleomycin.
Key exclusion criteria (5 listed)
- Patients with genital warts
- Patients on systemic steroids or other immunosuppressive treatments
- Immunocompromised individuals
- Patients suffering from chronic systemic diseases
- Pregnant women
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 |
|---|---|---|
| endoplasmic reticulum Aminopeptidase 1 and 2endoplasmic reticulum aminopeptidase1 and 2 serum levels determination via ELISA | Diagnostic test | – |
| endoplasmic reticulum aminopeptidase 1 and 2 serum levels determination via ELISAAlso: SEUM ERAP1 MEASUREMENT USING ELISA, SERUM ERAP2MEASUREMENT USING ELISAendoplasmic reticulum aminopeptidase 1 and 2 serum levels determination via ELISA | Diagnostic test | – |
Primary outcome
SERUM LEVELS OF endoplasmic reticulum aminopeptidase 1 and 2
Time frame: ONE YEAR
using specific Commercial human ELISA kits
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Warts
Enrolling by invitationPhase 1/2
Base-Edited Hematopoietic Stem/Progenitor Cell Gene Therapy for Treatment of CXCR4-WHIM
WHIM, Warts
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
RecruitingPhase 2
Treatment of Recurrent Genital Warts by Combination of CO2 Laser and Geniwa Gel
HPV (Human Papillomavirus)-Associated, Genital 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)
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.
Ihab Y. Abdallah, MD study chair
Professor of Dermatology, Venereology and Andrology, Faculty of Medicine, Benha University
Nehad A.Fouad, MD study director
Professor of Microbiology and Immunology, Faculty of Medicine, Benha University
Ola S Ebrahim, MBBCh principal investigator
Benha University
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 Warts, run by Benha 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 5 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: finished, as of the sponsor's last update on 18 Feb 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SERUM LEVELS OF endoplasmic reticulum aminopeptidase 1 and 2 (time frame: ONE 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 18 Feb 2025.