Clinical Trial: Clinical Trial With Local Decitabine Treatment of HPV-Induced VIN Grade 2/3 (DelVIN)
Study Status: COMPLETED
Recruit Status: COMPLETED
Condition: Vulvar Intraepithelial Neoplasia Grade 2
Study Type: INTERVENTIONAL
Official Title: The DelVIN Trial - A Multicenter Phase I Trial Evaluating the Safety and Preliminary Efficacy of Local Decitabine Treatment of Human Papillomavirus (HPV)-Induced Vulvar Intraepithelial Neoplasia (VIN)
Brief Summary:
This is a multicentre open labelled phase I trial evaluating the safety and preliminary efficacy of local decitabine treatment of human papillomavirus (HPV)-induced vulvar intraepithelial neoplasia (VIN) grade 2/3.The main purpose and primary objective of the study is to determine the recommended phase 2 dose (RP2D) of VTD-101 ointment for the topical treatment of HPV-induced VIN grade 2/3.The RP2D is defined as the dose that is safe, tolerable and effective.Corresponding endpoints are the rate of…
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