Condyloma accuminata, Vulvar Intraepithelial Neoplasia MedDRA version: 9.1 Level: HLT Classification code 10047762 Term: Vulval neoplasms benign MedDRA version: 9.1 Level: LLT Classification code 10010291 Term: Condyloma acuminatum
Conditions
Interventions
Trade Name: Aldara
Product Name: Aldara 5% Cream
Product Code: EU/1/98/080/001
Pharmaceutical Form: Cream
INN or Proposed INN: IMIQUIMOD
CAS Number: 99011-02-6
Concentration unit: % (V/V) percent volu
Sponsors
Medizinische Universität Wien, Universitätsklinik für dermatologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Female patients with histologically proven Vulvar Intraepithelial Neoplasia 2/3 and/or anogenital Condyloma acuminata, Age 18-50, informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Malignancy, Pregnancy, Therapeutic Immunosupression, severe systemic dermatologic disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The occurrence and clinical course of human papillomavirus (HPV)-induced lesions is largely determined by the nature of the cellular immune defense generated. Even though both genital warts and vulvar intraepithelial neoplasia (VIN) are HPV-associated genital tumors they differ in their risk of malignant progression: while genital warts are benign neoplasms (low-risk HPV types), VIN can progress to vulvar carcinomas (high-risk HPV types). 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. ;Secondary Objective: ;Primary end point(s): Primary Endpoint 1) What is the proportion of histologically and clinically complete responses vs. partial responses after 16 weeks of IMQ therapy in patients with genital warts and VIN2 or 3? 2) What are the differences in HPV-affected and non-affected, “normal” tissue at a cellular and molecular level, as determined by immunofluorescence stainings and real-time PCR, respectively? | — |
Countries
Austria
Outcome results
None listed