Prospective multicenter clinical trial of a minimally invasive temperature controlled bipolar fractional radiofrequency system for rhytid and laxity treatment

100 subjects with mild to severe facial rhytides were treated at seven centers in the United States. Treatment included single-pass fractional RF (FRF) treatment and dermal handpiece insertions. The results were improvement in wrinkles (Fitzpatrick Wrinkle Scale) and satisfaction from an overwhelming majority of patients.

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)