Photoaging
Conditions
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.
Interventions
PROCEDURETreatment one side BLE by NAFL
One side of the patient face underwent treatment using the ResurFX module of M22 (Lumenis Co., Yokneam, Israel) randomly.
PROCEDURETreatment another side BLE by FMR
One side of the patient face underwent treatment using FMR device (INFINI, Lutronic Co., Goyang-si, Korea).
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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). |
| 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). |
Countries
China
Contacts
Primary ContactWenjie Dou, bachelor
Outcome results
None listed