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

- Drug: Imiquimod
Local Imiquimod three times weekly for 16 weeksOther Name: Aldara
- 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 ]
- Proportion of histological and clinical response to therapy after 16 weeks of IMQ therapy [ Time Frame: 16 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

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
Austria | |
Stephan Polterauer | |
Vienna, Austria, A-1090 |
Principal Investigator: | Georg Stingl, Prof. | Medical University of Vienna |
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 |
Neoplasms Imiquimod Adjuvants, Immunologic Immunologic Factors |
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