The ThermaCool TC system is a radiofrequency device capable of delivering higher energy fluences to a greater volume of tissue than nonablative lasers, with no epidermal injury. It has been successful in treating periorbital rhytides and lifting eyebrows. Given these positive finding for treatment of the upper face, the device has been recently applied to rejuvenate and tighten the skin on the lower face and upper neck. This study shows the efficacy and patient satisfaction with this application. Data were compiled over a 6-month period from patients treated with the ThermaCool TC system on the lower face. Up to 3 areas were treated: cheeks, jawline, and upper neck. Treatment parameters and adverse events were recorded and digital photographs taken. Telephone interviews were then conducted after the treatment to assess patient satisfaction. Sixteen patients underwent treatment of the lower face during this period. Eleven of the patients had all three areas (cheeks, jawline, and neck) treated. Two patients had only the cheeks and jawline treated, and 3 patients underwent treatment of the cheeks only. The average level was 14.6 for the cheeks with the average energy of 113.8 joules per pulse. The average treatment level of the jawline was 14.0, with the average energy of 107.0 joules per pulse. The average level was 13.8 for the neck, at the average energy of 99.7 joules per pulse. All patients experienced mild erythema and edema of the treatment areas as expected, and all resolved within 48 hours post-treatment. Fifteen of the 16 patients were available for interview. Ten patients found the results unsatisfactory while five patients were satisfied. Four of 11 (36%) patients who had all 3 areas treated reported satisfactory results, compared to 1 of 4 (25%) of patients who had only 1 or 2 areas treated. The satisfactory group consistently was higher in both dial setting and energy per pulse. Furthermore, the average age of the unsatisfactory group was 58, compared to 51 of the satisfactory group. Photographic analysis of pre- and post-treatment digital images did not yield statistically significant results. Our study adds the growing body of information on this new device. Radiofrequency causes movement of charged particles within the tissue, and the resultant molecular motion generates heat. The heat in turn causes collagen shrinkage and new collagen deposition. Based on our findings, younger patients tend to respond better. This is not surprising, since heat-labile collagen bonds are progressively replaced by irreducible multivalent cross-links as the tissue ages. Second, higher dial settings and corresponding higher energy per pulse correlated with better response. Third, those who had the entire surface area of the face and neck treated tend to do better than those with partial treatment. The data from the study give us critical clues in refining this exciting new technology for cosmetic uses and beyond.
The 532 nm KTP and 1,064 nm Nd: YAG lasers can be effectively and safely used for non-invasive skin rejuvenation.
No abstract
Background: DaxibotulinumtoxinA for Injection (DAXI) is a novel botulinum toxin type A formulation in clinical development. A phase 2 dose-ranging study identified an optimal dose and demonstrated efficacy with a median duration of 24 weeks. Methods: In two phase 3, multicenter, randomized, double-blind, placebo-controlled studies (SAKURA 1 and SAKURA 2), subjects with moderate or severe glabellar lines at maximum frown were assigned randomly to receive placebo or 40 U of DAXI. Glabellar lines were evaluated at least every 4 weeks for at least 24 weeks until severity returned to baseline (≤36 weeks). Results: Overall, 609 subjects were enrolled (DAXI, n = 405; placebo, n = 204). DAXI was significantly more effective than placebo in achieving the primary efficacy outcome (≥2-point improvement in glabellar line severity at maximum frown at week 4 according to both investigator and subject ratings): 73.6 percent versus 0.0 percent (SAKURA 1), and 74.0 percent versus 1.0 percent (SAKURA 2) (both p < 0.0001). Composite investigator and subject ratings of maximum frown after DAXI treatment showed that glabellar line severity of none or mild was maintained for a median of 24.0 weeks (SAKURA 1) and 23.9 weeks (SAKURA 2), and glabellar line severity did not return to baseline levels for a median of 27.7 and 26.0 weeks, respectively. DAXI was generally well tolerated, with the most common adverse events related to DAXI treatment being headache (SAKURA 1, 7.0 percent; SAKURA 2, 5.9 percent) and injection-site pain (5.0 percent and 2.4 percent, respectively). Conclusions: Results from both studies were highly consistent. DAXI may offer a prolonged duration of response (median, ≥24 weeks) and is generally well tolerated. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.
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