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

Xijing Hospital15 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Photoaging

Interventions

Treatment one side BLE by NAFLPROCEDURE

One side of the patient face underwent treatment using the ResurFX module of M22 (Lumenis Co., Yokneam, Israel) randomly.

Treatment another side BLE by FMRPROCEDURE

One side of the patient face underwent treatment using FMR device (INFINI, Lutronic Co., Goyang-si, Korea).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients with Bags lower eyelids ( BLEs )； 2. Two senior attending surgeons diagnosed the BLEs; 3. The clinical diagnosis standard was mild swelling or puffiness under the eyes; 4. Between 18 to 60 years old. Exclusion Criteria: 1. History of retinoic acid; 2. History of hormone use; 3. History of keloids; 4. History of injection of botulinum toxin or filler at the site of treatment; 5. Skin inflammation or facial infection; 6. Pregnancy or lactation.

Locations (1)

Department of Plastic Surgery, Xijing Hospital

Xi'an, Shaanxi, China

RECRUITING

Outcomes

Primary Outcomes

Patient Satisfaction Scores(PSS)

Patients scored their satisfaction used 10-point Visual analogue scales (VAS, 0 = unsatisfied, 10= very satisfied)

Time frame: Change from Baseline PSS at 1-month after 3rd treatment, Change from Baseline PSS at 3-month after 3rd treatment, Change from 1-month after 3rd treatment PSS at 3-month after 3rd treatment.

Blinded Investigator Assesement(BIA)

The physician's severity score of standard photographs used VAS 0-4(VAS, 0 = no eyelid bags, 4= very obvious eyelid bags)

Time frame: Change from Baseline BIA at 1-month after 3rd treatment, Change from Baseline BIA at 3-month after 3rd treatment, Change from 1-month after 3rd treatment BIA at 3-month after 3rd treatment.

Periorbital wrinkles assessment by VISIA system(VISIA)

VISIA Complexion Analysis System (Canfield Imaging Systems, Fairfield, New Jersey, USA)

Time frame: Change from Baseline VISIA at 1-month after 3rd treatment, Change from Baseline VISIA at 3-month after 3rd treatment, Change from 1-month after 3rd treatment VISIA at 3-month after 3rd treatment.

Change of BLEs by ANTERA-3D(ANTERA-3D)

volume of elevations (mm3), elevation area (mm2), and the maximum peak height volume of elevations (mm3), elevation area (mm2), and the maximum peak height We assessment the volume(mm3), elevation area (mm2), and the maximum peak height (mm) of elevations(mm) by ANRERA-3D camera (Miravex Limited, Ireland).

Time frame: Change from Baseline ANTERA-3D at 1-month after 3rd treatment, Change from Baseline ANTERA-3D at 3-month after 3rd treatment, Change from 1-month after 3rd treatment ANTERA-3D at 3-month after 3rd treatment.

Orbital fat depth and length by CineScan assessment(CineScan)

Orbital fat depth(mm) and length(mm) by CineScan Ultrasonic Ophthalmic A and B scan System (Quantel Medical Inc., Bozeman, Montana, USA).

Time frame: Change from Baseline CineScan at 1-month after 3rd treatment, Change from Baseline CineScan at 3-month after 3rd treatment, Change from 1-month after 3rd treatment CineScan at 3-month after 3rd treatment.

Central Contacts

Wenjie Dou, bachelor

CONTACT

+8602984775306 790623705@qq.com

Data from ClinicalTrials.gov

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