Randomized, blinded, 3-arm clinical trial assessing optimal temperature and duration for treatment with minimally invasive fractional radiofrequency.
BACKGROUND
A previous multicenter clinical trial of a needle-based fractional radiofrequency (FRF) treatment for facial and neck rhytides and laxity counterintuitively demonstrated a mean target temperature and treatment duration of 69.5 °C and 4.9 seconds for subjects with lesser improvement and 67 °C and 4.2 seconds for greater improvement.


OBJECTIVE
To determine optimal temperature and duration settings for maximal clinical results in rhytides and laxity from a single FRF treatment of the face and neck.


METHODS
A randomized, blinded, 3-arm clinical evaluation of FRF at a series of temperatures from 52-57 °C to 67 °C. Three blinded plastic surgeons and dermatologists scored rhytides using the Fitzpatrick Wrinkle Assessment Scale and laxity using the Alexiades Laxity Assessment Scale at 1, 3, and 6 months.


RESULTS
Blinded grading showed optimal improvement at 67 °C and 3 seconds and decreased efficacy below 67 °C, with mean rhytide reductions of 40, 29, and 25% and mean laxity reductions of 34, 36, and 25% in Arms 3 (67 °C), 2 (62 °C), and 1 (52 °C-57 °C), respectively. A 100% response rate was observed for all subjects treated at 62 °C to 67 °C target temperature.


CONCLUSIONS
The optimal target dermal temperature for facial and neck rhytide and laxity treatment is 67 °C and duration of 3 to 4 seconds with a 100% response rate after a single FRF treatment.
*Department of Dermatology, Yale University School of Medicine, New Haven, Connecticut; †Dermatology and Laser Surgery Center, New York, New York; ‡Syneron Medical, Inc., Milpitas, California.
Macrene
M
Alexiades
Dany
D
Berube
D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D005145:Face / Q000528:radiation effects*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009333:Neck / Q000528:radiation effects*; D061208:Pulsed Radiofrequency Treatment / Q000379:methods; D015361:Rhytidoplasty / Q000379:methods; D012720:Severity of Illness Index; D015595:Skin Aging / Q000528:radiation effects*; D013696:Temperature; D016896:Treatment Outcome