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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

Page last updated: August 23, 2015

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