RT3 VIN

• Research type

  Research Study

• Full title

  A trial of topical treatment for vulval intraepithelial neoplasia (RT3 VIN trial)

• IRAS ID

  1

• Contact name

  Jeanette Isaac

• Sponsor organisation

  Cardiff University

• Eudract number

  2006-004327-11

• ISRCTN Number

  34420460

• Research summary

  VIN is a skin condition affecting the vulval skin which, if untreated, may become cancerous. Symptoms include itching, burning, soreness and discolouration of the vulval skin. Currently the main treatment options for patients are surgery or laser treatment, neither of which guarantee a cure and can cause physical and psychological problems. What is needed, is a topical treatment (e.g. a cream or a gel) that women can apply in the privacy of their own homes that's effective in treating VIN. There have been a few, small scale studies that have shown that two topical treatments (imiquimod and cidofovir) may have the potential to treat VIN. RT3VIN is a randomised trial of topical treatments in women with VIN. Women with VIN 3 will be randomised to receive either imiquimod or cidofovir. The purpose of this research is to determine whether there is evidence that either of these topical treatments is active, safe and feasible to use. Before the start of protocol treatment, biopsies will be taken for HPV testing. HPV is thought to be one of the reasons why VIN develops and this trial will test for HPV both before and after treatment to see if the HPV has gone. The imiquimod or cidofovir will be applied by the patient for a maximum of 24 weeks. Participants will be reviewed every six weeks. The VIN lesion(s) will be assessed at each visit to see how they are responding to treatment. At each visit participants will also be asked about their symptoms, any toxicities, and how often the treatment has been used. Participants whose lesions completely disappear will be followed up to observe any recurrence for two years. Some participants, for whom there is no improvement or disease progression may have the option to be treated with the alternative topical treatment.

• REC name

  HSC REC B

• REC reference

  08/NIR03/82

• Date of REC Opinion

  23 Oct 2008

• REC opinion

  Further Information Favourable Opinion