BACKGROUND:Non-surgical treatment of the aging lower face remains a therapeutic challenge. Tissue Micro-Coring Technology (MCT) is a novel technology that permits the non-surgical removal of skin as micro-cores, tightening skin and inducing collagen and elastin. OBJECTIVE:To evaluate safety and efficacy of MCT for the treatment of the aging lower face. METHODS:This retrospective, single-site study assessed outcomes for subjects treated with MCT. Assessments included the change from baseline in Lemperle Wrinkle Severity Scale (LWSS) assessed for the nasolabial folds (NLF), marionette lines, lip lines, and global esthetic improvement scale (I-GAIS). RESULTS:A total of 10 patients met the study criteria. Mean (SD) I-GAIS was 1.7 (0.36), and mean (SD) change from baseline in LWSS for NLF, marionette lines, and lip lines were 1.1 (0.46), 1.3 (0.3), and 0.6 (0.35), respectively. Most subjects had some improvement in LWSS across all three treatment areas, with many experiencing > 1-point improvements. LIMITATIONS:Limitations include the retrospective study design, small study population, and single-sex population. CONCLUSION:In the real-world setting, MCT leads to improvements in global appearance and wrinkle severity. MCT is an effective alternative to injectable fillers for the treatment of nasolabial fold and marionette and perioral lines.
BACKGROUND:Radiofrequency microneedling (RFMN) is a minimally invasive procedure that promotes skin remodeling and tightening through radiofrequency-generated thermal energy. On October 15, 2025, the US FDA issued a warning on RFMN devices due to reports of serious complications. OBJECTIVE:To assess the adverse events (AEs) related to commercially available RFMN devices, data were collected from the FDA's manufacturer and user facility device experience (MAUDE) database, which collects medical device reports for suspected injuries. METHODS:Search query for AEs involving RFMN devices from 2020 to 2025 included search terms for the mechanism of action, brand names, and device manufacturers. RESULTS:A total of 86 medical device reports associated with RFMN devices were reported in the MAUDE database from 2020 to 2025, with 145 reported AEs. The most reported side effects were fat loss, scarring, and postinflammatory erythema. CONCLUSION:The MAUDE database serves as a valuable tool for reporting AEs. Adjustment of settings based on the patient and indication as well as real-time device feedback mechanisms can further improve patient safety outcomes.
BACKGROUND:There is a lack of evidence-based consensus to assist clinicians in using photobiomodulation (PBM). OBJECTIVE:To create a consensus on the safe and effective use of PBM. METHODS:A systematic literature review of Embase and MEDLINE was conducted in June 2022 to identify publications reporting research on PBM. An international multidisciplinary panel was convened to draft recommendations informed by the systematic search; they were refined through 2 rounds of Delphi survey, 2 consensus meetings, and iterative review by all panelists until unanimous consensus was achieved. RESULTS:A multidisciplinary panel of experts (n = 21) was assembled based on publication history. The key findings that informed the consensus developed by the expert panel were as follows: PBM is a safe treatment modality for adult patients and red light PBM does not induce DNA damage. PBM is an effective treatment option for peripheral neuropathy, androgenic alopecia, wound ulcers due to multiple etiologies, decubitus ulcers, pain attributed to diabetic foot ulcers, and acute radiation dermatitis. CONCLUSION:The systematic literature search and structured Delphi consensus approach culminated in an evidence-based clinical practice guideline for safe and effective use of PBM in medical and aesthetic applications. Future research will further bolster our understanding of this evolving noninvasive technique.
OBJECTIVE:We sought to evaluate the safety and efficacy of an electrical muscle stimulation (EMS) device in the improvement of muscle strength and toning of the upper extremities. This device, which is FDA-cleared as a two-channel muscle stimulator, provides up to eight electrodes with waveforms inducing muscle stimulation. Although a prior study demonstrated it is safe and effective for use in the abdomen, this system, which has electrodes specifically designed for the extremities, has not previously been evaluated in the upper extremities.METHODS:Forty-five subjects enrolled in the study to assess improvement in arm (i.e., bicep and tricep muscle) strength, and appearance following a protocol of treatments with this bioelectric muscle activation (BMA) device. All subjects received four 30-min EMS treatment sessions in Arm mode-twice weekly for 2 weeks and at least 48 h apart. Follow up visits were also scheduled 30- and 90-days after treatment. Strength was measured with a dynamometer device at baseline, at the final treatment session, and at the posttreatment 30- and 90-day assessment. Subject satisfaction was assessed gauging overall comfort of the treatment and satisfaction including willingness to recommend to others. The changes in strength between initial treatment and final treatment, as well as 30 and 90-day assessment were evaluated. Clinical photography at these visits was also assessed for each patient. Patients were instructed to not modify their normal exercise routine while participating in this study.RESULTS:All 45 subjects completed the treatment protocol. Most patients showed an improvement in muscle strength from the initial to final treatment (i.e., the fourth treatment). Specifically, the maximum bicep strength increased by a mean of 7.5 lbs (22.83%, p = 0.006), while the average increased by a mean of 8.2 lbs (25.76%, p = 0.001) during this period. Similarly, the maximum tricep strength from initial to final treatment increased by a mean of 10.0 lbs (23.16%, p = 0.000), while the average increased by a mean of 9.6 lbs (27.12%, p = 0.000). Thirty days after the last treatment, the maximum bicep strength increased by a mean of 13.3 lbs (34.13%, p = 0.001) while the average increased by a mean of 13.6 lbs (37.05%, p = 0.000) during this period. Similarly, the maximum tricep strength from initial to 30 days postfinal treatment increased by a mean of 10.9 lbs (24.37%, p = 0.000), while the average increased by a mean of 10.5 lbs (29.37%, p = 0.000). Finally, 90 days after the last treatment, the maximum bicep strength increased by a mean of 19.4 lbs (48.4%, p = 0.000), while the average increased by a mean of 17.4 lbs (46.53%, p = 0.000) during this period. Similarly, the maximum tricep strength from initial to 90 days postfinal treatment increased by a mean of 10.8 lbs (27.12%, p = 0.000), while the average increased by a mean of 10.0 lbs (30.94%, p = 0.001).CONCLUSION:This device was well tolerated and resulted in increased strength measurements in the upper extremities, as assessed by a dynamometer, which were sustained at 30 and 90 days.
BACKGROUND Patients frequently seek treatment for vascular and pigmented lesions. More recently, a novel, variable-sequenced, long-pulsed, 532-nm and 1,064-nm laser with cryogen spray cooling was developed to offer greater flexibility in treatments. OBJECTIVE A prospective clinical trial evaluated the safety and efficacy of a novel, variable-sequenced, long-pulsed, 532-nm and 1,064-nm laser with cryogen spray cooling (DermaV, Lutronic, South Korea). MATERIALS AND METHODS Subjects with vascular and/or pigmented lesions were enrolled and underwent laser treatments. RESULTS Twenty-three subjects were enrolled with vascular lesions (39.1%), pigmented lesions (17.4%), and both (43.5%). Mean age was 53.1 years, and 91.3% were women. Fitzpatrick skin types II–IV were included. All subjects were treated with 532 nm, and 4 were also treated with 1,064 nm. According to 4 blinded physician reviewers, correct before and after photographs were selected in 94.7%, 92.1%, 84.2%, and 76.3% of cases. Overall, 86.8% were responders, meaning that at least 3 of 4 reviewers agreed. For Global Aesthetic Improvement Scale, improvement occurred in 81.6%, 81.6%, 81.6%, and 76.3% of cases. No serious adverse events occurred. Overall, 87.0% of subjects reported being very satisfied or satisfied. CONCLUSION A novel, variable-sequenced, long-pulsed, 532-nm and 1,064-nm laser with cryogen spray cooling can safely and effectively improve vascular and pigmented lesions.
