Clinical trial NCT04237324: Efficacy of Fractional Microneedle Radiofrequency and Fractional Erbium-Doped Glass 1,565-nm for Baggy Lower Eyelids
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Photoaging
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient Satisfaction Scores(PSS)
timeFrame: 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.
measure: Blinded Investigator Assesement(BIA)
timeFrame: 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.
measure: Periorbital wrinkles assessment by VISIA system(VISIA)
timeFrame: 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.
measure: Change of BLEs by ANTERA-3D(ANTERA-3D)
timeFrame: 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.
measure: Orbital fat depth and length by CineScan assessment(CineScan)
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of Plastic Surgery, Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Department of Plastic Surgery,Xijing Hospital
name: Xianjie Ma, Ph.D
role: PRINCIPAL_INVESTIGATOR
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