Clinical trial · Interventional
Human Papilloma Virus Genotypes and Treatment Outcomes of Intralesional Immunotherapy of Anogenital Warts
NCT05761002CI-TRIAL-00064570unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to investigate the relationship between HPV genotypes and treatment outcomes of intralesional immunotherapy of anogenital warts with the quadrivalent vaccine (Gardasil).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anogenital Wart | — | UNRESOLVED | — |
| Human Papilloma Virus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| the Quadrivalent Vaccine (Gardasil) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment group
- description
- All patients will be subjected to: * A thorough history taking and proper dermatological examination. * Skin sampling from anogenital wart lesions: skin sterilization followed by injection of local anesthesia at the base of lesions, then the part of wart above skin surface will be removed using shave biopsy technique. * DNA extraction of skin samples. * Conventional PCR for low-risk HPV genotypes (6,11) and RT-PCR for high-risk HPV genotypes. * 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.
- interventionNames
- Biological: the Quadrivalent Vaccine (Gardasil)
Primary outcomes (1)
- measure
- improvement of lesion
- timeFrame
- 6 month
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.