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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Photoaging

Intervention / Treatment
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* Procedure: Treatment one side BLE by NAFL
* Procedure: Treatment another side BLE by FMR


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The purpose of this study is to assess the safety and efficacy of FMR and NAFL for the treatment of BLEs in Asian. After being informed about the study and potential risks, all patients giving written informed consent. Patients were randomly divided into FMR side and NAFL opposite side 3 times in total at a 1-month interval. FMR side has been used by FMR device (INFINI, Lutronic Co., Goyang-si, Korea) and the NAFL side has been used by ResurFX module of M22 (Lumenis Co., Yokneam, Israel).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NAFL group<br>One side of the patient face has been therapied by 1565nm fiber nonablative fractional laser(Lumenis Co., Yokneam, Israel). | Procedure: Treatment one side BLE by NAFL<br>* One side of the patient face underwent treatment using the ResurFX module of M22 (Lumenis Co., Yokneam, Israel) randomly.<br>|
| Active Comparator: FMR group<br>Another side of the patient face has been therapied by FMR device (INFINI, Lutronic Co., Goyang-si, Korea). | Procedure: Treatment another side BLE by FMR<br>* One side of the patient face underwent treatment using FMR device (INFINI, Lutronic Co., Goyang-si, Korea).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction Scores(PSS) | Patients scored their satisfaction used 10-point Visual analogue scales (VAS, 0 = unsatisfied, 10= very satisfied) | 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) | 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) | 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). | 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). | 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. |