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

Air Force Military Medical University of People's Liberation Army

Status: Unknown

Conditions: Photoaging

Treatments: Procedure: Treatment another side BLE by FMR; Procedure: Treatment one side BLE by NAFL

Study type: Interventional

Funder types: Other

Identifiers

NCT04237324

No.KY20172045-C-1

Details and patient eligibility

About

The purpose of this study was to compare the efficacy and safety of FMR and NAFL in the treatment of baggy lower eyelids(BLEs)

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

15 participants in 2 patient groups

NAFL group

Experimental group

Description:

One side of the patient face has been therapied by 1565nm fiber nonablative fractional laser(Lumenis Co., Yokneam, Israel).

Treatment:

Procedure: Treatment one side BLE by NAFL

FMR group

Active Comparator group

Description:

Another side of the patient face has been therapied by FMR device (INFINI, Lutronic Co., Goyang-si, Korea).

Treatment:

Procedure: Treatment another side BLE by FMR