Immunevasion of Human Papillomavirus (HPV) in Vulvar Intraepithelial Neoplasia 2/3 and Anogenital Warts and Efficiency and Mechanisms of Imiquimod Treatment

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00941811

Enrollment

Registered

2009-07-20

Start date

2008-12-31

Completion date

2010-05-31

Last updated

2015-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HPV

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.

Interventions

DRUGImiquimod

Local Imiquimod three times weekly for 16 weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Analysis of Cellular and Molecular Mechanisms of Imiquimod tretament and differences in HPV afeected and non affected tissue at cellular and molecular level	16 weeks

Secondary

Measure	Time frame
Proportion of histological and clinical response to therapy after 16 weeks of IMQ therapy	16 weeks

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026