Objective: This study was undertaken to study the tolerability and efficacy of 5% imiquimod cream in the primary treatment of vulva intraepithelial neoplasia (VIN) grade 2/3.
Study design: VIN grade 2/3 patients were recruited from regional colposcopy units. Imiquimod cream was applied over the abnormal area by the patient using an escalating dose regime for total treatment duration of 16 weeks. At the end of study, repeat colposcopy and biopsy of the target lesion were performed to assess for response.
Results: Twenty-three patients participated. Twenty patients (87%) had VIN grade 3. Nine patients (39%) had multifocal disease on colposcopy. Therapy was well tolerated with the most commonly observed side effects being irritation at the application site. Responses were evaluable in 17 patients. Complete responses were observed in 9 patients with partial responses in another 5 (relative risk 82%). The median time to response was 7 weeks.
Conclusion: Imiquimod cream can induce histologic regression of high-grade VIN lesions and is well tolerated using a slow dose-escalating regime.