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
18 Years
N/A
Female
HPV
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Analysis of Cellular and Molecular Mechanisms of Imiquimod tretament and differences in HPV afeected and non affected tissue at cellular and molecular level
Outcome Time Frame:
16 weeks
Safety Issue:
Yes
Principal Investigator
Georg Stingl, Prof.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Medical University of Vienna
Authority:
Austria: Austrian Agency for Health and Food Safety (AGES)
Study ID:
_1.0
NCT ID:
NCT00941811
Start Date:
December 2008
Completion Date:
May 2010
Related Keywords:
- HPV
- Neoplasms
- Condylomata Acuminata
- Carcinoma in Situ
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