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

HPV Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00941811
• Other study ID #: _1.0
• Secondary ID: ISRCTN: 2008-004
• Status: Completed
• Phase: Phase 2
• First received: July 16, 2009
• Last updated: June 14, 2015
• Start date: December 2008
• Est. completion date: May 2010

Study information

• Verified date: June 2015
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Austrian Agency for Health and Food Safety (AGES)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: May 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma in Situ
• HPV

Intervention

Drug:
• Imiquimod
Local Imiquimod three times weekly for 16 weeks

Locations

Country	Name	City	State
Austria	Stephan Polterauer	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of Cellular and Molecular Mechanisms of Imiquimod tretament and differences in HPV afeected and non affected tissue at cellular and molecular level		16 weeks	Yes
Secondary	Proportion of histological and clinical response to therapy after 16 weeks of IMQ therapy		16 weeks	Yes