An interventional study of Treatment one side BLE by NAFL and Treatment another side BLE by FMR in Photoaging, sponsored by Xijing Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-01-23.
Sponsored by Xijing Hospital · Not applicable, Interventional, and Treatment
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.
Xijing Hospital is the lead sponsor of 465 studies on the registry; 157 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
One side of the patient face underwent treatment using the ResurFX module of M22 (Lumenis Co., Yokneam, Israel) randomly.
One side of the patient face underwent treatment using FMR device (INFINI, Lutronic Co., Goyang-si, Korea).
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.
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Plan to share: No — Individual participant data (IPD) will not be shared for patient privacy
This study is status unknown, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Xijing Hospital