NESTOR Mark S (Dermatologist - United States)

evaluation of the efficacy and safety of micro-focused ultrasound for the treatment of axillary hyperhidrosis

Lecture number: 2136

Background:
The objective of this study was to evaluate the efficacy and safety of micro-focused ultrasound (Ultherapy) for treatment of primary axillary hyperhidrosis. Methods: Contralateral randomized sham controlled trial with the treatment arm: two passes using the 4MHz-4.5mm transducer, and two passes using the 7MHz-3.0mm transducer (Group A (N=20)). Subjects received 2 treatments 28 days apart. A separate group B (N=3) received active on both axilla to evaluate pre-treatment injections of lidocaine (lido) or lidocaine with epinephrine (lido/epi) on one axilla only to evaluate pain and effect of injection. Efficacy at 7, 14 and 30 days post-treatment #1 and 2 measured by gravimetric sweat production method. Pain scores were assessed by a 10-pt VAS scale and safety was assessed. Results: Average age 37 years (26-58 years), 90% female, 30% Caucasian, 30% Hispanic/Latino, 30% African American and 10% Asian. At interim time point, active treatment resulted in average sweat reduction of 77.5%, 87.1%, and 96.0% at 7, 14, and 30d post-treatment #1, and 92.2%, 93.6, and 93.4% at 7, 14, and 30d post-treatment #2. Sham averaged 29.7%, -87.8%, and -112.6% (negative value = increased sweat) at 7, 14 and 30d post-treatment #1, and -95.3%, -11.3% and -29.6%, post-treatment #2. Starch iodine showed qualitative reductions in sweat for active vs. sham. Group B pain scores averaged 7.6±1.2, 3.8±2.5, and 1.3±1.5 with no analgesics, lido, and lido/epi, respectively. Lido/epi resulted in longer lasting pain control. No serious adverse events were reported. AE’s were limited to mild to moderate tenderness and bruising. Conclusion: Preliminary results suggest micro-focused ultrasound (Ulthera System) appears efficacious and safe for the treatment of axillary hyperhidrosis. Lido/epi provided superior, pain control. Larger scale trials are warranted.