Safety and Tolerability of the Derma Vax Electroporation System

目的：我们的主要目的是：评估EMLA乳膏作为表面麻醉剂或安慰剂预处理后使用Derma Vax进行皮内电穿孔（IDEP）的安全性和耐受性，并确定EMLA乳膏应用于电穿孔部位是否显着减少与IDEP手术相关的疼痛。我们的次要目标是：使用视觉模拟量表确定IDEP的疼痛感知程度；使用McGill疼痛量表来确定IDEP期间疼痛感知的质量；确定IDEP后疼痛等级和皮肤刺激的时间过程，并确定使用和不使用EMLA乳膏以及参与者之间皮肤阻力的变化。

Objectives: Our primary objectives are: to assess safety and tolerability of Intradermal electroporation (IDEP) using Derma Vax administered after pretreatment with either EMLA cream as topical anesthetic or with placebo and to determine if the EMLA cream applied to the electroporation site significantly decreases pain associated with the IDEP procedure. Our secondary objectives are: to determine the magnitude of pain perception of IDEP using a Visual Analog Scale; to determine the quality of pain perception during IDEP using the McGill pain scale; to determine the time course after IDEP of pain rating and skin irritation and to determine variations in skin resistance with and without EMLA cream and between participants. Experimental Design and Methods: Twelve healthy men or women will be recruited for this study. This is a randomized double-blind, placebo-controlled study with a medical device. Each subject will receive EMLA cream or control cream placed on the electroporation site on each deltoid area in a blinded randomized manner. This will be followed by IDEP administration to each pre-treated deltoid area. Medical Relevance and Expected Outcome: DNA vaccines are a promising treatment for infectious diseases and cancer. The ideal delivery method for induction of cellular and humoral immune responses has not been defined. Information from this study is necessary for future studies using Derma Vax in therapeutic DNA vaccine studies. Derma Vax is unique in its proprieties of delivering a series of electric pulses that provoke DNA uptake by antigen presenting cells that reside in the dermal layer of the skin. We expect that the application of Intradermal Electroporation (IDEP) using Derma Vax will be well tolerated and the use of EMLA cream will decrease the pain compared to placebo.