Jaggy Rao, MD* , MD Division of Dermatology, University of Alberta Edmonton, Alberta, Canada

Preliminary Study

To evaluate the safety, tolerability and effectiveness of transdermal Hyaluronic Acid (HA) delivery using Dermelectroporation®

Study Design

• 10 healthy female subjects
• Symmetrical periorbital rhytids
• Randomization: Only RIGHT or LEFT face treated
• Efficacy Parameters:
  – Photography
  – Histology
  – Blinded dermatologist assessment
  – Subject questionnaires

Materials and Methods

Materials

• Hyaluronic Acid 15 mg/ml, very low viscosity from Apothécure, Inc., Dallas, Texas
• Ultrapeel® + TransDerm Ionto® from Mattioli Engineering, Florence, Italy

Methods

• Side to be treated scrubbed with acetone
• Periorbital region treated with microdermabrasion
• 3.0 milliliters of HA transdermally delivered per Tx approximately 5 – 10 minutes per session (Picture 2)
• Two transdermal treatments given, 2 weeks apart
• Mupirocin ointment immediately post-treatment
• 2 mm punch biopsies at 4 weeks post-treatment

Results

• Minimal and transient side effects
  – erythema (10), mild abrasions (6), purpura (1)
• All subjects tolerated the treatments well
  – average Tolerability Score = 2.2*
• Subject questionnaires
  – average Improvement Score = 3.2**
  • 1 = no discomfort,
  • 2 = mild discomfort,
  • 3 = moderate discomfort,
  • 4 = severe discomfort
  ** 1 = no improvement, 2 = mild improvement, 3 = moderate improvement, and 4 = dramatic improvement
• Average change in Wrinkle Class (1 – 5) *
  – Treated Side = – 1.3
  – Control Side = – 0.2
• Pre- and 4-week follow-up photos evaluated by four independent blinded physician observers
  – Average improvement treated side = 3.3 **
  – Average improvement control side = 1.2 **
  * As determined by blinded dermatologist reviewer
  ** 1 = no improvement,
  2 = mild improvement,
  3 = moderate improvement,
  4 = dramatic improvement

Conclusions and Implications

• Through Dermoelectroporation®, transdermal drug delivery of HA is possible and safe
• This concept may improve the efficiency of other biological agents and drugs such as anesthetics, anti inflammatory, and photosensitizers
• New studies are in progress to further examine the potential scope of this process