Prospective multicenter clinical trial of a temperature-controlled subcutaneous microneedle fractional bipolar radiofrequency system for the treatment of cellulite

50 female subjects with cellulite were treated at four different clinical sites with a single Profound SubQ treatment. A blind assessment of photos was performed by three dermatologists and results showed significant success.

PubMed Reference:Alexiades M, Munavalli G, Goldberg D, Berube D. Dermatol Surg. 2018 Oct;44(10):1262-1271. 

Study Details: 

• 50 female subjects (mean age 44±9 years, range 25-63 years) with cellulite Stage II or III (Nurnberger-Muller scale classification) treated on 100 thighs at 4 USA clinical sites
• Single Profound Sub-Q treatment to the upper posterolateral thighs (~15x15cm area): 67^ºC target tissue temperature and 4-second pulse duration; 3-4 mm spacing between adjacent needle insertions
• 3 dermatologists - blinded assessment of photos according to FDA guidance - dimple number and severity of undulation irregularities, using a 5-point scale (0=none to 4=severe)

Study Results: 

• 93% success rate for independent assessment per thigh on blinded evaluation
• Significant reduction in dimples and undulations
• 75% of subjects reported satisfaction with treatment outcome
• Procedural pain level was 3.74±1.96 on a 10-point scale (0=no pain) with 82% of subjects experiencing no discomfort to mild discomfort
• Post-procedural erythema and edema were common and resolved within ~2 days on average
• No adverse events associated with treatment