Clinical and immunological effects of imiquimod and HPV-vaccination compared to imiquimod alone in female patients with Usual type VIN - Effects of HPV-vaccination and imiquimod in VIN patients

• Conditions: In this trial, the efficacy of Gardasil combined with imiquimod in women with usual type Vulvar Intraepithelial Neoplasia is investigated.; MedDRA version: 9.1Level: LLTClassification code 10047778Term: Vulvar cancer in situ; MedDRA version: 9.1Level: LLTClassification code 10066416Term: Vulvovaginal human papilloma virus infection; MedDRA version: 9.1Level: LLTClassification code 10046859Term: Vaccination; MedDRA version: 9.1Level: LLTClassification code 10062059Term: Histology abnormal

• Registration Number: EUCTR2008-008251-42-NL
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

-Histological proven usual type VIN, without invasion
-Previous treatment with imiquimod for 12-16 weeks with a partial response to
imiquimod treatment defined as a reduction in lesion size of 26%-99%
-The patient is willing to use a medically acceptable method of contraception throughout the study
-Age 18 and above

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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-(Micro-)invasive carcinoma
-Pregnancy and/or breastfeeding
-Past history of vulvar cancer
-Differentiated (non HPV-related) VIN
-Other treatment of VIN or anogenital warts within 1 month of start trial
-Hypersensitivity to any components of the vaccine or cream formulation
-History of psoriasis or other inflammatory dermatosis of the vulva
-Immunodeficiency (e.g. HIV, systemic corticosteroid use)
-Insufficient understanding of the Dutch language
-Partial responders who are disease-free at study-entry due to other treatment of VIN

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified