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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Stephan Polterauer, Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT00941811

First received: July 16, 2009

Last updated: June 14, 2015

Last verified: June 2015

History of Changes

Purpose

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.

Condition	Intervention	Phase
HPV	Drug: Imiquimod	Phase 2


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

Resource links provided by NLM:

MedlinePlus related topics: Warts

Drug Information available for: Imiquimod

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:

Analysis of Cellular and Molecular Mechanisms of Imiquimod tretament and differences in HPV afeected and non affected tissue at cellular and molecular level [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Proportion of histological and clinical response to therapy after 16 weeks of IMQ therapy [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]


Enrollment:	5
Study Start Date:	December 2008
Study Completion Date:	May 2010
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Local Imiquimod three times weekly for 16 weeks

Other Name: Aldara

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00941811

Locations


Austria
Stephan Polterauer
Vienna, Austria, A-1090

Sponsors and Collaborators

Medical University of Vienna

Investigators


Principal Investigator:	Georg Stingl, Prof.	Medical University of Vienna

More Information


Responsible Party:	Stephan Polterauer, md, Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00941811 History of Changes
Other Study ID Numbers:	_1.0 ISRCTN: 2008-004893-42
Study First Received:	July 16, 2009
Last Updated:	June 14, 2015
Health Authority:	Austria: Austrian Agency for Health and Food Safety (AGES)

Additional relevant MeSH terms:


Carcinoma in Situ Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Imiquimod	Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents Interferon Inducers

ClinicalTrials.gov processed this record on September 28, 2016

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