A randomized, split-face controlled trial on the safety and effects of microneedle fractional radiofrequency and fractional erbium-doped glass 1,565-nm laser therapies for baggy lower eyelids.

Abstract

The non-ablative fractional erbium-doped glass 1,565-nm laser (NAFL) and the microneedle fractional radiofrequency (MFR) procedures are effective treatments that enable periorbital skin rejuvenation. To compare the clinical effectiveness and side effects of MFR and the NAFL for baggy lower eyelids (BLEs) in the Chinese population. Fifteen Chinese subjects with BLEs received three split-face treatments on a monthly basis randomly. Objective and subjective assessments were performed at baseline, as well as 1 month and 3 months after the third treatment. The results were evaluated using Antera-3D and CineScan systems. Blinded investigator assessments were performed by two plastic surgeons using a 0 to 4 score in six anatomic categories of BLEs. The patients also reported their level of satisfaction based on a four-point score. Most of the patients reported a greater than 47% satisfaction rate with both treatments. The cumulative contribution scores of prolapse of orbital fat, hollow tear trough, and skin laxity for each category variable declined with time. Using Antera 3D, the volume of elevation (mm³) decreased from 0.6 ± 0.4 to 0.4 ± 0.3 and from 0.6 ± 0.3 to 0.3 ± 0.3, the elevation area (mm²) decreased from 17.0 ± 8.4 to 13.0 ± 7.1 and from 17.0 ± 7.8 to 10.0 ± 5.6, and the maximum peak height (mm) also decreased from 0.10 ± 0.04 to 0.06 ± 0.04 and from 0.10 ± 0.03 to 0.06 ± 0.02 in the MFR and NAFL groups, respectively. Using CineScan, the depth of middle orbital fat (mm) decreased significantly from 10.2 ± 2.2 to 8.0 ± 0.7 and from 9.8 ± 1.1 to 8.0 ± 0.9 and the length of orbital fat significantly decreased from 9.2 ± 1.2 to 7.7 ± 0.7 and from 9.7 ± 1.4 to 7.8 ± 0.6 in the MFR and NAFL groups, respectively. MFR and NAFL therapies were effective for the treatment of BLEs, especially in BLE patients with skin elasticity in addition to tear trough deformity and orbital fat prolapse.

Trial registration number: NCT04237324.

Trial register: ClinicalTrials.gov.

Level of evidence: Level I, therapeutic study.