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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00941811
First Posted: July 20, 2009
Last Update Posted: June 16, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stephan Polterauer, Medical University of Vienna
  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
Intervention Model: Single Group Assignment
Masking: Single (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:


Further study details as provided by Stephan Polterauer, 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 ]

Secondary Outcome Measures:
  • Proportion of histological and clinical response to therapy after 16 weeks of IMQ therapy [ Time Frame: 16 weeks ]

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:
    Drug: Imiquimod
    Local Imiquimod three times weekly for 16 weeks
    Other Name: Aldara
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: July 16, 2009
First Posted: July 20, 2009
Last Update Posted: June 16, 2015
Last Verified: June 2015

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