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

Phase 2

Completed

• Conditions: Vulval Intraepithelial Neoplasia; Cancer

• Registration Number: ISRCTN34420460
• Lead Sponsor: Cardiff University (UK)

Brief Summary

2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25304851 results 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29336101 long-term follow-up results (added 05/08/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-09-25
• Study Completion: 2013-01-01
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 180

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Histologically confirmed complete response by 30 weeks after start of treatment.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Symptomatic improvement, assessed at each 6-weekly visit<br> 2. Compliance and side effects, assessed at each 6-weekly visit<br> 3. Viral clearance, assessed 6 weeks after the participants stop treatment<br> 4. Human PapillomaVirus (HPV) type and integration status, assessed 6 weeks after the participants stop treatment<br> 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<br>