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

Not Applicable

• Conditions: Photoaging
• Interventions: Procedure: Treatment one side BLE by NAFL; Procedure: Treatment another side BLE by FMR

• Registration Number: NCT04237324
• Lead Sponsor: Xijing Hospital

Brief 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.

Study Timeline

• Study Start: 2018-01-01
• Status Verified: 2019-11
• Study First Submitted: 2019-12-24
• Study First Submitted QC: 2020-01-19
• Last Update Submitted: 2020-01-19
• Study First Posted: 2020-01-23
• Last Update Posted: 2020-01-23
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NAFL group	Treatment one side BLE by NAFL	One side of the patient face has been therapied by 1565nm fiber nonablative fractional laser(Lumenis Co., Yokneam, Israel).
FMR group	Treatment another side BLE by FMR	Another side of the patient face has been therapied by FMR device (INFINI, Lutronic Co., Goyang-si, Korea).

Primary Outcome Measures

Name	Time	Method
Blinded Investigator Assesement(BIA)	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.	The physician's severity score of standard photographs used VAS 0-4(VAS, 0 = no eyelid bags, 4= very obvious eyelid bags)
Periorbital wrinkles assessment by VISIA system(VISIA)	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.	VISIA Complexion Analysis System (Canfield Imaging Systems, Fairfield, New Jersey, USA)
Orbital fat depth and length by CineScan assessment(CineScan)	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.	Orbital fat depth(mm) and length(mm) by CineScan Ultrasonic Ophthalmic A and B scan System (Quantel Medical Inc., Bozeman, Montana, USA).
Patient Satisfaction Scores(PSS)	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.	Patients scored their satisfaction used 10-point Visual analogue scales (VAS, 0 = unsatisfied, 10= very satisfied)
Change of BLEs by ANTERA-3D(ANTERA-3D)	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.	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).

Trial Locations

Locations (1)

Department of Plastic Surgery, Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China