Immunevasion of Human Papillomavirus (HPV) in Vulvar Intraepithelial Neoplasia 2/3 and Anogenital Warts and Efficiency and Mechanisms of Imiquimod Treatment

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medical University of Vienna
• Treatments: Imiquimod

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