A Randomised phase II multi-centre Trial of topical treatment in women with Vulval Intraepithelial Neoplasia

A Randomised phase II multi-centre Trial of topical treatment in women with Vulval Intraepithelial Neoplasia (TR3-VIN)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN34420460

Enrollment

204

Registered

2007-09-25

Start date

2008-01-01

Completion date

Unknown

Last updated

2022-04-19

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

Conditions

Vulval Intraepithelial Neoplasia Cancer Vulval Intraepithelial Neoplasia

Interventions

Topical treatment with either imiquimod or cidofovir will be applied by the patient for a maximum of 24 weeks. In both treatments the patient should use as much cream as needed to adequately cover the

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Women with biopsy proven Vulval Intraepithelial Neoplasia 3 (VIN3) (including visible peri-anal disease not extending into the anal canal) 2. At least one lesion of sufficient size to allow biopsies (greater than or equal to 1 cm2) 3. Informed consent

Exclusion criteria

Exclusion criteria: 1. Any patients with impaired renal function 2. Any patient with current anogenital carcinoma or any patient who, in the investigators opinion, is at a high risk of developing invasive disease (patients in whom invasive or microinvasive disease is suspected should have adequate biopsies to exclude this prior to entry) 3. Pregnancy, breast feeding or trying to conceive 4. Active treatment for VIN within the previous four weeks 5. Patients who are under 18 years old 6. Known allergy to either of the topical treatments 7. Unable to comply with protocol treatment 8. Prior failure of imiquimod or cidofovir following treatment 3 times a week for a minimum of 12 weeks

Design outcomes

Primary

Measure	Time frame
Histologically confirmed complete response by 30 weeks after start of treatment.	—

Secondary

Measure	Time frame
1. Symptomatic improvement, assessed at each 6-weekly visit 2. Compliance and side effects, assessed at each 6-weekly visit 3. Viral clearance, assessed 6 weeks after the participants stop treatment 4. Human PapillomaVirus (HPV) type and integration status, assessed 6 weeks after the participants stop treatment 5. Recurrence rate at two years (in 30 week complete responders). This will be assessed 6 monthly for 2 years from the end of treatment visit	—

Measure

Time frame

1. Symptomatic improvement, assessed at each 6-weekly visit 2. Compliance and side effects, assessed at each 6-weekly visit 3. Viral clearance, assessed 6 weeks after the participants stop treatment 4. Human PapillomaVirus (HPV) type and integration status, assessed 6 weeks after the participants stop treatment 5. Recurrence rate at two years (in 30 week complete responders). This will be assessed 6 monthly for 2 years from the end of treatment visit

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Countries

United Kingdom, Wales

Outcome results

None listed

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