Efficacy and Tolerability Assessment of a Multi-Probe, Radiofrequency-Based Medical Device for Facial Skin Rejuvenation and Abdominal Obesity Reduction: Two Pilot Clinical Studies Publisher



Samadi A ; Zandkarimi S ; Dabagh P ; Nasrollahi S A ; Yazdanparast T ; Maghsoudiashtiani M ; Firooz A
Source: Iranian Journal of Dermatology Published:2026

Abstract

Background: Aging and abdominal obesity are two cosmetic concerns that negatively affect patients’ self-confidence. Radiofrequency (RF) technology has proven effective in managing both issues. In this study, we aimed to assess the efficacy and tolerability of a fractional RF system (Study I) for skin rejuvenation and a combined RF/ low-frequency ultrasound (LFUS) system (Study II) for reducing abdominal obesity. Methods: Study I involved 19 participants (age: 44 ± 8.75 years) with facial skin wrinkles who received three fractional RF treatments over six weeks. Assessment methods included wrinkle grading by an independent investigator; objective measurements of the depth, area, and volume of the right nasolabial fold; dermal thickness and echo-density using high-frequency ultrasound; and evaluation of skin biophysical parameters. Study II included 10 patients with abdominal obesity who underwent eight weekly sessions of combination therapy using RF and low-frequency ultrasound. Reductions in abdominal circumference were evaluated after treatment. Results: In Study I, laxity and wrinkle scale scores were significantly reduced compared to baseline eight weeks after treatment (P = 0.004 and P = 0.014, respectively). There was also a significant improvement in skin elasticity parameters, as well as in the area and volume of nasolabial folds at the end of the eighth week. In Study II, BMI values did not differ significantly from baseline, while abdominal circumference showed a significant decrease at both measurement visits (P < 0.01). Adverse effects in both studies were mild, transient, and resolved within one week. Conclusion: fractional RF microneedling and combined RF/LFUS system were preliminarily safe and showed acceptable efficacy for skin rejuvenation and the reduction of abdominal obesity, respectively. © Iranian Journal of Dermatology.