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Primary Imiquimod Treatment Versus Surgery for Vulvar Intraepithelial Neoplasia


Phase 3
18 Years
90 Years
Open (Enrolling)
Female
Vulvar Intraepithelial Neoplasia

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Trial Information

Primary Imiquimod Treatment Versus Surgery for Vulvar Intraepithelial Neoplasia


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete clinical response

Outcome Description:

No clinical evidence of vulvar lesion, i.e. 100% reduction of primary lesion size

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Gerda Trutnovsky, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical University of Graz

Authority:

Austria: Agency for Health and Food Safety

Study ID:

KLI293

NCT ID:

NCT01861535

Start Date:

June 2013

Completion Date:

September 2016

Related Keywords:

  • Vulvar Intraepithelial Neoplasia
  • VIN
  • Imiquimod
  • Surgery
  • HPV
  • Patient satisfaction
  • Neoplasms
  • Carcinoma in Situ

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