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Clinical Papers

Prospective Multicenter Clinical Trial of a Minimally Invasive Temperature Controlled Bipolar Fractional Radiofrequency System for Rhytid and Laxity Treatment

PubMed Reference: Alexiades-Armenakas M, Newman J, Willey A, et al. Dermatol Surg. 2013;39(2):263-73.

Study Details: 

  • 100 subjects with mild to severe facial rhytides treated at 7 USA centers
  • Single-pass fractional RF (FRF) treatment (temp. 62 to 78°C, 3-5 sec energy, impedance restriction 200 - 3,000 Ohms)
  • Dermal handpiece (5 microneedle pairs) insertions every 3-4 mm for mild/moderate and 3-4 mm for severe rhytides
  • 5 physicians - blinded assessment of digital photos

Study Results: 

  • 100% response rate with average of 26% improvement in wrinkles (Fitzpatrick Wrinkle Scale)
  • >90% of patients were satisfied or very satisfied
  • Precise intradermal real-time temperature control
  • Minimal side effects only (i.e. focal, palpable, but not visible edema at insertion sites)