Primary Imiquimod Treatment Versus Surgery for Vulvar Intraepithelial Neoplasia (PITVIN)

Medical University of Graz

Status and phase: Completed; Phase 3

Conditions: Vulvar Intraepithelial Neoplasia

Treatments: Drug: Imiquimod; Procedure: Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01861535

KLI293

Details and patient eligibility

About

To evaluate the efficacy (defined as complete clinical response at 6 months) of imiquimod vs. standard treatment (surgery) for vulvar intraepithelial neoplasia (VIN).

Enrollment: 110 patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed VIN (only usual type, formerly VIN 2-3)
• Visible, measurable lesion(s)
• Contraception (for premenopausal women)

Exclusion criteria

• Evidence of invasion
• History of cancer or severe inflammatory dermatosis of the vulva
• Pregnancy, lactation
• Immunodeficiency
• Any treatment for VIN within the previous three months
• Known hypersensitivity to imiquimod

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Primary Imiquimod

Experimental group

Description:

Treatment with imiquimod will be patient self-administered for a period of 4 months with possible extension to 6 months. A thin layer of imiquimod cream should be applied to the lesion and remain overnight without a cover. Application will be once a week for 2 weeks, then twice a week the following 2 weeks and, if tolerated, 3 times a week for the last weeks. In case of severe side-effects the number of applications can be reduced; a treatment-free period of no more than 1 week is permitted

Treatment:

Drug: Imiquimod

Primary surgery

Active Comparator group

Description:

The type of surgery (excision or ablation) will be based on clinical findings and surgeon's judgement. After excision the specimen will be histologically analyzed to assess resection margins and rule out invasion.

Treatment:

Procedure: Surgery