Primary Imiquimod Treatment versus Surgery for a precancerous condition of the vulva

Primary Imiquimod Treatment versus Surgery for Vulvar Intraepithelial Neoplasia: A Prospective Randomized Controlled Trial - PITVIN

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002052-17-AT

Enrollment

110

Registered

2012-09-12

Start date

2012-09-21

Completion date

Unknown

Last updated

2021-03-17

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

Conditions

Vulvar intraepithelial neoplasia MedDRA version: 17.0 Level: LLT Classification code 10056574 Term: Vulval intraepithelial neoplasia System Organ Class: 100000004872

Interventions

Trade Name: Aldara 5% cream Product Name: not applicable Pharmaceutical Form: Cream INN or Proposed INN: IMIQUIMOD CAS Number: 99011-02-6 Concentration unit: mg milligram(s) Concentration type: equal

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Histologically confirmed VIN (only usual type, formerly VIN 2-3) • Visible, measurable lesion(s) • Age 18 -90 years • Contraception (for premenopausal women) • 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: • Evidence of invasion • History of cancer or inflammatory dermatosis of the vulva • Pregnancy, lactation • Immunodeficiency • Any treatment for VIN within the previous month • Known hypersensitivity to imiquimod

Design outcomes

Primary

Measure	Time frame
Main Objective: The present study aims to compare primary imiquimod treatment with the standard treatment (surgery) for treatment of VIN (complete clinical response).;Secondary Objective: To compare primary imiquimod treatment with the standard treatment (surgery) for histologic response, amount and extent of surgical interventions, mutilation/scarring of the vulva, psychosexual impact, HPV clearance and long term recurrence rate.;Primary end point(s): rate of complete clinical response at 6 months ;Timepoint(s) of evaluation of this end point: 6 months after start of treatment	—

Measure

Time frame

Main Objective: The present study aims to compare primary imiquimod treatment with the standard treatment (surgery) for treatment of VIN (complete clinical response).;Secondary Objective: To compare primary imiquimod treatment with the standard treatment (surgery) for histologic response, amount and extent of surgical interventions, mutilation/scarring of the vulva, psychosexual impact, HPV clearance and long term recurrence rate.;Primary end point(s): rate of complete clinical response at 6 months ;Timepoint(s) of evaluation of this end point: 6 months after start of treatment

—

Secondary

Measure	Time frame
Secondary end point(s): •complete clinical response at 12 months • histologic response at 6 and 12 months • amount and extent of surgical interventions for VIN • mutilation of the vulva • psychosexual distress • clearance of HPV virus • the long-term recurrence rate ;Timepoint(s) of evaluation of this end point: 6 and 12 months after start of treatment	—

Countries

Austria

Contacts

Public ContactUniv.- Frauenklinik Graz

Medizinische Universität Graz

kks@medunigraz.at43316385 12150

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026