- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05761002
Human Papilloma Virus Genotypes and Treatment Outcomes of Intralesional Immunotherapy of Anogenital Warts
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Human papillomavirus (HPV), a member of the Papillomaviridae family, is a small, icosahedral, non-enveloped virus with a circular double-stranded DNA genome. Sexually transmitted HPV, which mainly infects mucosal and keratinized epithelium, has a cytopathic effect on the epithelium. Genital mucosal HPV infection is persistent and multifocal and can be subclinical (Alacam & Bakir, 2021). Infection with HPV causes a large proportion of cervical, vaginal, vulvar, anal, and penile cancers, as well as genital warts (Choi, 2019).
Anogenital warts are common benign dermatological conditions caused by different HPV genotypes, with serotypes 6, 11, 16, and 18 being the most causative types (Santos-López et al., 2015). Their prevalence varies according to geographical locations. Data is not yet available on the HPV burden in the general population of Egypt (Elazab et al., 2021). In October 2014, a very important multicenter observational study in Egypt concluded that the prevalence of HPV among Egyptian women aged 18 years or more is about 10.4%, with the highest prevalence of HPV infection being observed among women aged 45-54 years (Shaltout et al., 2014).
Different modalities are available for the treatment of warts, such as topical podophyllin, imiquimod, podophyllotoxin, or trichloroacetic acid, surgical excision, electrosurgery, cryosurgery, laser surgery, and intralesional immunotherapy (Gill, 2021; Nofal et al., 2022). Available treatments are time-consuming, painful, and can leave scars or hypopigmentation. Furthermore, recurrence rates after any treatment range from 6% to 100% (Ciccarese et al., 2019). As a result, there has been a demand for safer modalities to treat recalcitrant warts. Immunotherapy presents an alternative approach to the management of warts as it provides ease of application, but even distant lesions get resolved with application to a single lesion. Immunotherapy has been performed with imiquimod, BCG vaccine, HPV vaccines, and auto implantation therapy (Gill, 2021).
Three HPV vaccines are licensed as protective measures against the development of genital warts, cervical cancer, and other anogenital cancers. They include the bivalent vaccine targeting serotypes 16/18 (Cervarix), the quadrivalent vaccine targeting serotypes 6/11/16/18 (Gardasil), and the nonavalent vaccine targeting serotypes 6/11/16/18/31/33/45/52/58 (Gardasil-9) (Vaccine Information Statement | HPV | VIS | CDC, 2021). There is a strong immune response against the HPV vaccine that not only causes the clearance of local wart lesions but also causes the clearance of distant lesions. The vaccine is designed to elicit neutralizing antibody responses which prevent initial infection with HPV, but in warts it mainly acts by mounting cell-mediated and humoral responses which help in the clearance of warts. The quadrivalent HPV vaccine contains inactive L1 proteins from four different strains: 6, 11, 16, and 18; synthesized in the yeast Saccharomyces cerevisiae (Gill, 2021).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Zagazig, Egypt, 44519
- Recruiting
- Rana Ehab
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Contact:
- rana ehab, md
- Phone Number: 01000896453
- Email: ranaehab015@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with clinically diagnosed multiple anogenital warts who had not received treatment in the last 2 months before the study
Exclusion Criteria:
- Patient refusal, pregnancy, lactation, age less than 10 years, and immunosuppressive conditions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: treatment group
All patients will be subjected to:
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• Intralesional injection of the quadrivalent HPV vaccine (Gardasil) at a dose of 0.5ml, into the largest wart at 4-week intervals until complete clearance is achieved or for a maximum of three sessions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
improvement of lesion
Time Frame: 6 month
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The response will be considered complete if there is disappearance of the warts, partial if the warts regressed in size by 50-99% and no response if there is 0-49% decrease in wart size.
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6 month
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Virus Diseases
- Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- DNA Virus Infections
- Skin Diseases, Infectious
- Papillomavirus Infections
- Skin Diseases, Viral
- Tumor Virus Infections
- Neoplasms, Squamous Cell
- Warts
- Papilloma
- Condylomata Acuminata
Other Study ID Numbers
- 94412022
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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