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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:
Medical University of Vienna
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
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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 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:
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| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00941811
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 |
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 June 26, 2017