Safety and Efficacy of Micro-focused Ultrasound Plus Visualization for the Treatment of Axillary Hyperhidrosis.

OBJECTIVES: To evaluate the safety, efficacy, and durability of treating axillary hyperhidrosis with high-intensity micro-focused ultrasound plus visualization.

DESIGN: Two randomized double-blind, sham-controlled pilot studies.

MEASUREMENTS: For Study 1, the primary endpoint was response defined as ≥50-percent reduction in baseline sweat production as measured gravimetrically. For Study 2, the primary endpoint was response defined as a reduction of Hyperhidrosis Disease Severity Scale scores from 3 or 4 to 1 or 2. Secondary endpoints included changes in gravimetric and starch-iodine testing and patient satisfaction.

RESULTS: In Study 1, ≥50 percent of patients achieved a positive treatment response. In Study 2, the response rate at post-treatment Day 60 for micro-focused ultrasound plus visualization- (N=12) and sham-treated (N=8) patients was 67 and zero percent, respectively (p=0.005). Patients evaluated 12 months after treatment (N=11) demonstrated the long-lasting effectiveness of micro-focused ultrasound plus visualization for treating axillary hyperhidrosis. All but one patient in the micro-focused ultrasound plus visualization group were satisfied with their results while all sham group patients were dissatisfied (p=0.0001). Subjective reports of greatest improvement were sweat production (92%) and social embarrassment (83%). Adverse events were found to be mild and were resolved within a short timeframe.

CONCLUSION: Micro-focused ultrasound plus visualization appears to be safe, effective, well-tolerated, and a long-lasting means for treating axillary hyperhidrosis.