A new transdermal device, transderm ionto, can effectively allow the penetration of 2% lidocaine into the skin to minimize pai
Center for Clinical & Cosmetic Research
Abstract February Pilot clinical study to evaluate the efficacy of the Transdermal Ionto device to minimize pain and discomfort associated with dermatological cosmetic procedures Mark Nestor, MD, PhD and Alex Cazzaniga Center for Cosmetic Enhancement, Aventura, Florida The Transderm Ionto (Mattioli Engineering, Italy S.p.A.) is a medical device that allows
transferring active substances and drugs into the skin without the use of needles using a
new method called “Dermoelectroporation”. The Transderm Ionto use special shaped
pulsed currents to transfer alternately positive and negative ions of active substances into
the skin. The purpose of this pilot study was to evaluate the efficacy of the Transdermal
Ionto device to allow the penetration of an anesthetic solution into the skin and
comparing with the standard methodology used for pain management of a dermatological
cosmetic procedure. The abdomens of ten volunteers were used for this study. Each
abdomen was divided into 4 zones of 8cm x 8cm and each zone was randomly treated by
either A) topical anesthetic cream containing 5% lidocaine under occlusion for 60
minutes, B) Transdermal Ionto lidocaine hydrochloride 2% – 1:100,000 epinephrine after
a light microdermabrasion with vibration level 2 and between 3 to 5 mA for 5-7 minutes
dispensing 0.6ml/hr of solution via the Precision Liquid Dispenser (PLD), C)
Transdermal Ionto dispensing water via the PLD at same rate after a light
microdermabrasion with vibration level 2 and between 3 to 5 mA for 5- 7 minutes
(control) and D) no pretreatment (control). Two of the 10 patients were sensitive to these
treatment parameters and the treatment was done at 1-3 mA for the same length of time.
Each volunteer used a 0 to 10 point visual scale to grade the sensation of pain. Pain
sensation was induced using a radiofrequency device at energy levels ranging from 53 to
115 J/cm2. The mean pain scores obtained were 4.3 for the area treated with the topical
anesthetic cream; 3.4 for the Transdermal Ionto with the anesthetic solution; 6.7 for the
2925 Aventura Blvd., Suite 205 • Miami, Florida 33180 Phone: 305-933-5923 • Fax 305-933-6720
Center for Clinical & Cosmetic Research
Transdermal Ionto with water and 7.6 for the untreated area. The results obtained from
the Transderm Ionto with lidocaine were statistical significant vs. the topical anesthetic
cream (p<0.01) and all the other treatments (p<0.001). The results clearly show that the
Transdermal Ionto device can effectively allow the penetration of lidocaine into the skin
at those settings and can be used as an anesthetic device to minimize potential pain and
discomfort during dermatological cosmetic procedures. These results warrant future
studies with different parameters for optimization of pain management and reduction of
10 patients Ionto + 2% lidocaine Ionto + water 2925 Aventura Blvd., Suite 205 • Miami, Florida 33180 Phone: 305-933-5923 • Fax 305-933-6720
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Center for Clinical & Cosmetic Research
Center for Clinical & Cosmetic Research
Transdermal Ionto with water and 7.6 for the untreated area. The results obtained from
the Transderm Ionto with lidocaine were statistical significant vs. the topical anesthetic
cream (p<0.01) and all the other treatments (p<0.001). The results clearly show that the
Transdermal Ionto device can effectively allow the penetration of lidocaine into the skin
at those settings and can be used as an anesthetic device to minimize potential pain and
discomfort during dermatological cosmetic procedures. These results warrant future
studies with different parameters for optimization of pain management and reduction of
10 patients