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Vulvar Intraepithelial NeoplasiaPhase 3PITVINNCT01861535

Primary Imiquimod Treatment Versus Surgery for Vulvar Intraepithelial Neoplasia

A Phase 3 study testing Imiquimod and Surgery in people with Vulvar Intraepithelial Neoplasia, run by Medical University of Graz at 9 sites in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 90 years, women only
Conditions the study is for
Vulvar Intraepithelial Neoplasia
What is being tested?
Imiquimod and Surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
9 sitesAustria
Study dates
Jun 2013to Feb 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

9 sites in 1 country.

9 sites in 1 country

Austria9 sites

  • Dep. of Gynecology, Krankenhaus Barmherzige Brüder Graz

    Graz, Styria, 8020

  • Department of Obstetrics and Gynecology/ Medical University of Graz

    Graz, 8036

  • Department of Gynecology and Obstetrics, Medical University of Innsbruck

    Innsbruck, 6020

  • Dep. of Gynecology and Obstetrics, Klinikum Klagenfurt

    Klagenfurt

  • Dep. of Gynecology and Obstetrics

    Leoben

  • Dep. of Gynecology and Obstetrics, Landes Frauen- und Kinderklinik Linz

    Linz, Upper Austria, 4020

  • Dep. of Gynecology, Krankenhaus Barmherzige Schwestern Linz

    Linz, 4010

  • Dep. of Gynecology and Obstetrics, Landeskrankenhaus Salzburg

    Salzburg, 5020

  • Department of General Gynecology and Gynecology Oncology, Medical University of Vienna

    Vienna, 1090

Other trials in Austria

About this study

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

Being tested
Imiquimod, Surgery
Keywords
VIN, Imiquimod, Surgery, HPV, Patient satisfaction
Medical subject headings
Patient Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ImiquimodDrug

    Also called Aldara

  • SurgeryProcedure or surgery

    Also called Excision, Ablation

Study groups in NCT01861535
Study groupRoleWhat they receive
Primary ImiquimodExperimentalTreatment 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
Receives: Drug: Imiquimod
Primary surgeryActive comparatorThe 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.
Receives: Procedure: Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete clinical response

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

    Measured: 6 months

Secondary outcomes (7)

  1. Clinical response/ lesion size

    Vulvar lesions will be described, measured with calipers, mapped and photographed. The digital photos will be analyzed with a computer program (ImageJ) to calculate the total lesion size in cm². Results will be classified as: no response (NR, reduction in lesion size of 25% or less), weak partial response (wPR, 26-75% reduction), strong partial response (stPR, 76%-99% reduction) and Complete response (CR, 100% reduction).

    Measured: 6 months

  2. Histologic response

    At baseline punch biopsies will be taken from the affected areas. The site of the initial biopsy will be photodocumented to ensure that the follow-up biopsy at 6 months is taken from the same site. Histologic results will be classified as response (R): complete disappearance of usual type VIN or reduction to VIN1,or no response (NR). All biopsy samples will be analysed independently by two experienced gynecologic pathologists unaware of the treatment allocation

    Measured: 6 months

  3. Extent of surgery

    The number, types and extent of surgical procedures will be recorded. The extent of surgery will be recorded as total operated lesion size (in cm², as measured on pre-operative photograph) and relative operated lesion size (percentage of operated lesion size compared with the original pretreatment lesion size)

    Measured: 6 months

  4. HPV status

    HPV status will be measured with the qualitative cobas® HPV Test, Roche, and the the APTIMA ® HPV assay, Gen-Probe.

    Measured: 6 months

  5. Clinical response/lesion size

    Vulvar lesions will be described, measured with calipers, mapped and photographed. The digital photos will be analyzed with a computer program (ImageJ) to calculate the total lesion size in cm². Results will be classified as: no response (NR, reduction in lesion size of 25% or less), weak partial response (wPR, 26-75% reduction), strong partial response (stPR, 76%-99% reduction) and Complete response (CR, 100% reduction).

    Measured: 12 months

  6. Extent of surgery

    The number, types and extent of surgical procedures will be recorded. The extent of surgery will be recorded as total operated lesion size (in cm², as measured on pre-operative photograph) and relative operated lesion size (percentage of operated lesion size compared with the original pretreatment lesion size)

    Measured: 12 months

  7. HPV status

    HPV status will be measured with the qualitative cobas® HPV Test, Roche, and the the APTIMA ® HPV assay, Gen-Probe.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionFeb 2021
  4. Study completionFeb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01861535
Sponsor's protocol ID
KLI293
Acronym
PITVIN
Status last verified
Apr 2021
First submitted
6 May 2013
Last updated
14 Apr 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Trutnovsky G, Muntinga C, Holter M, Pucher D, Bracic T, Huetter C, Ciresa-Konig A, Polterauer S, Tamussino K, van Esch E. Risk factors for recurrence of vulvar high-grade squamous intra-epithelial lesions: long-term follow-up of the PITVIN Study (primary imiquimod vs surgery for vulvar intra-epithelial neoplasia). Int J Gynecol Cancer. 2026 Apr;36(4):104560. doi: 10.1016/j.ijgc.2026.104560. Epub 2026 Feb 11.

    PubMed 41791272

  • Muntinga CLP, de Vos van Steenwijk PJ, Kooreman LFS, Regauer S, Abdulrahman Z, Bekkers RLM, van der Burg SH, Trutnovsky G, van Esch EMG. Pre-existing infiltration with T cells and CD14+ myeloid cells is associated with treatment response to imiquimod in primary and recurrent vulvar high-grade squamous intraepithelial lesions. J Immunother Cancer. 2025 Oct 20;13(10):e012666. doi: 10.1136/jitc-2025-012666.

    PubMed 41120128

  • Trutnovsky G, Reich O, Joura EA, Holter M, Ciresa-Konig A, Widschwendter A, Schauer C, Bogner G, Jan Z, Boandl A, Kalteis MS, Regauer S, Tamussino K. Topical imiquimod versus surgery for vulvar intraepithelial neoplasia: a multicentre, randomised, phase 3, non-inferiority trial. Lancet. 2022 May 7;399(10337):1790-1798. doi: 10.1016/S0140-6736(22)00469-X. Epub 2022 Apr 25.

    PubMed 35483400

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Imiquimod and Surgery in people with Vulvar Intraepithelial Neoplasia, run by Medical University of Graz at 9 sites in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete clinical response (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01861535, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021.

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