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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

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ClinicalTrials.gov Identifier: NCT00941811
Recruitment Status : Completed
First Posted : July 20, 2009
Last Update Posted : June 16, 2015
Sponsor:
Information provided by (Responsible Party):
Stephan Polterauer, Medical University of Vienna

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
HPV Drug: Imiquimod Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
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
Study Start Date : December 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Warts
Drug Information available for: Imiquimod

Arms and Interventions
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Intervention Details:
  • Drug: Imiquimod
    Local Imiquimod three times weekly for 16 weeks
    Other Name: Aldara

Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Proportion of histological and clinical response to therapy after 16 weeks of IMQ therapy [ Time Frame: 16 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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Austria
Stephan Polterauer
Vienna, Austria, A-1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Georg Stingl, Prof. Medical University of Vienna
More Information
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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 Posted: July 20, 2009    Key Record Dates
Last Update Posted: June 16, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Neoplasms
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
 Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers