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Existing treatments for primary axillary hyperhidrosis have had limited success and acceptance. A new non-invasive microwave device was developed to target the interface between the dermis and the subcutaneous tissue, with controlled heating to eliminate sweat glands. A multicenter, randomized, sham-controlled clinical trial investigated the efficacy and safety of this new device.
Methods:
The study was performed in 120 adult subjects with primary axillary hyperhidrosis (Hyperhidrosis Disease Severity Score of 3 or 4). Subjects were randomized to a treatment group (n=81) or sham group (n=39) and were treated in two sessions spaced two weeks apart. Each axilla was marked using a template, anesthetized using local anesthesia, and treated using a device handpiece that was placed at the marked locations on the skin to accurately deliver microwave energy. Follow-up was 6 months for the sham group and 12 months for the treatment group.
Results:
The mean age of subjects was 32.8 years; 58% of the subjects were female, and 84% Caucasian.
The primary efficacy measure was the percentage of patients that had HDSS scores reduced to 1 or 2 (implying sweat that was not noticeable or was tolerable). Results for the treatment group were 89% at 30-days post-treatment, 74% at 3-months, 67% at 6-months, 69% at 9-months, and 69% at 12-months. Sham group results were 54% at 30-days, 44% at 3-months, and 44% at 6-months (p<0.001 at 30 days, p=0.001 at 3 months, p=0.019 at 6 months) It is also interesting to look at the percentage of subjects with at least a one point drop in HDSS score. At the 30-day visit 91% of subjects showed some improvement; this value was stable at 81% from the 3 month visit to the final 12 month visit. Sham group results were 70% (30-days), 57% (3-months) and 47% (6-months).
Treatment-related adverse events were generally mild and all but one completely resolved. The most common adverse events in the treatment group were transient patches of altered sensation in the skin of the treated arm (n=9, 9.9%). Most subjects experienced transient post-treatment local sequelae in the axilla including edema, tenderness, and bruising.
Conclusion:
A new microwave-based device and procedure has been developed for treating axillary hyperhidrosis, with results that show high efficacy and promising stability for long-term relief.