NCT04237324

Efficacy of Fractional Microneedle Radiofrequency and Fractional Erbium-Doped Glass 1,565-nm for Baggy Lower Eyelids

A Prospective, Randomized Controlled Split-face Trial of a Fractional Microneedle Radiofrequency Device（FMR） and Fractional Erbium-Doped Glass 1,565-nm Device(NAFL) Therapy in Baggy Lower Eyelids

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to compare the efficacy and safety of FMR and NAFL in the treatment of baggy lower eyelids(BLEs)

Detailed description

Fifteen baggy lower eyelids(BLEs) volunteers were recruited prospectively. Everyone was divided into two groups with FMR and NAFL according to the random number table. One side of the face was treated with FMR device and the other side was treated with NAFL device. Subjective and objective adverse reactions were recorded during the operation. Subjective adverse reactions were recorded after each treatment. The VAS score of patient satisfaction and the blind method score of standard photo observer were used for subjective evaluation, and the objective evaluation was carried out by using VISIA，Antera-3D and CineScan.

Conditions

• Photoaging

Interventions

Type	Name	Description
PROCEDURE	Treatment one side BLE by NAFL	One side of the patient face underwent treatment using the ResurFX module of M22 (Lumenis Co., Yokneam, Israel) randomly.
PROCEDURE	Treatment another side BLE by FMR	One side of the patient face underwent treatment using FMR device (INFINI, Lutronic Co., Goyang-si, Korea).

Timeline

• Start date: 2018-01-01
• Primary completion: 2021-12-30
• Completion: 2021-12-30
• First posted: 2020-01-23
• Last updated: 2020-01-23

Locations

1 site across 1 country: China