Onkodisruptor Electroporator : A pilot prospective study on Humans.

This article report on the data produced in the first human trial performed with our apparatus Onkodisruptor ©. The clinical study registered with EUDRACT N° 2014-003339-21 was performed under the direction of dr. Paola Pasquali  from the Dermatology Service, Pius Hospital De Valls, Tarragona, Spain, in collaboration with prof. Salvador Gonzalez from the Dermatology Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA and with the scientific department of our company. In detail, it was a phase III interventional, one center, open, prospective, randomized clinical trial on the effectiveness of intra-lesional bleomycin combined with electroporation for the treatment of plantar warts, in comparison to the use of intra-lesional bleomycin alone. The study cohort included 12 men and 10 female, with a mean of 53.8 years. A total of 22 warts were treated. Statistical analysis confirmed that the treatment with bleomycin combined with ECT respect to bleomycin alone provided a greater efficacy. Electroporation was always well tolerated by the patients with no discomfort.

Our scientific department is deeply involved in the definition of novel protocols for the treatment of different benign and locally malignant skin lesion by means of electroporation and this article represents the scientific rationale for ongoing studies on the use of Onkodisruptor © on human skin diseases.

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