Immunevasion of Human Papillomavirus (HPV) in Vulvar Intraepithelial Neoplasia 2/3 and Anogenital Warts and Efficiency and Mechanisms of Imiquimod Treatment
Information source: Medical University of Vienna
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HPV
Intervention: Imiquimod (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Medical University of Vienna Official(s) and/or principal investigator(s): Georg Stingl, Prof., Principal Investigator, Affiliation: Medical University of Vienna
Summary
The occurance and clinical course of human papillomavirus (HPV)-induced lesions is largely
determined by the nature of the cellular immune defense generated. Even tough both genital
warts and vulvar intraepithelial neoplasia (VIN) are HPV-associated genital lesions they
differ in their risk of malignant progression. Imiquimod (IMQ) is a topically applied
Toll-like receptor (TLR) 7 agonist that has been approved for the treatment of superficial
(pre-) carcinomas of the skin (basal cell carcinomas, actinic keratosis) and HPV-associated
lesions (genital warts). It acts by activation of the immune system exerting anti-tumor and
anti-viral properties. The aim of the study is to evaluate the mechanisms of IMQ treatment
and to analyze the differences in HPV-affected and non affected tissue at cellular and
molecular level as determined by immunofluorescence stainings and real time PCR,
respectively.
Clinical Details
Official title: An Explorative, Single Center and Controlled Study to Analyze the Immune Escape Mechanisms of HPV-associated Lesions and to Evaluate the Efficiency and Mechanisms of Imiquimod Treatment of Vulvar Intraepithelial Neoplasias 2/3 (VIN) and Anogenital Warts
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Analysis of Cellular and Molecular Mechanisms of Imiquimod tretament and differences in HPV afeected and non affected tissue at cellular and molecular level
Secondary outcome: Proportion of histological and clinical response to therapy after 16 weeks of IMQ therapy
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Female patients with histologically proven Vulvar Intraepithelial Neoplasia 2/3
and/or anogenital Condyloma acuminata
- Age 18-50
- Informed consent
Exclusion Criteria:
- Malignancy
- Pregnancy
- Therapeutic Immunosupression
- Severe systemic dermatologic disease
Locations and Contacts
Stephan Polterauer, Vienna A-1090, Austria
Additional Information
Starting date: December 2008
Last updated: June 14, 2015
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