Abstract
BACKGROUND: Primary axillary hyperhidrosis (PAH) is a chronic idiopathic disorder causing major stress in patients. Among the common therapies for PAH, only surgical interventions have proven feasible as a permanent solution. OBJECTIVE AND AIM: The aim of this study was to evaluate the efficacy and safety of fractional microneedle radiofrequency (FMR) as an alternative permanent treatment for PAH with long-term follow-up. MATERIALS AND METHODS: This was a single-blind, sham-controlled comparative study. Twenty-five patients with severe PAH were provided three treatments of FMR at 3-week intervals (the treatment group), and a control group was provided the sham treatment. Clinical efficacy was evaluated using the hyperhidrosis disease severity scale (HDSS) at baseline and the end of the study, as well as during the 1 year follow-up phase. RESULTS: HDSS demonstrated significant improvement after treatment in the treatment group compared to the sham control. The mean (±standard deviation) of HDSS in the group being treated with radiofrequency was 2.50 (±0.88) after 1 year follow-up, and that of the control group was 3.38 (±0.49; P < 0.001). Follow-up results show that there were 10 patients (41.6%) with no relapse and 11 patients (45.9%) with relapse after 1 year. There was a significant correlation between HDSS changes in relapse and body mass index (BMI) (P = 0.03). CONCLUSION: Treatment of PAH with FMR is a safe and noninvasive procedure with a positive therapeutic effect on HDSS. It is recommended, however, that sessions of FMR be repeated after 1 year, particularly in overweight patients with high BMIs. CLINICAL TRIAL REGISTRATION: IRCT2013111915455N1. LEVEL OF EVIDENCES: Level II-1.