Secret Micro-Needle Fractional RF System® for the Treatment of Facial Wrinkles

Aging Clinical Trial

Official title: A Prospective, Single-center, Investigator-blinded Trial to Evaluate the Safety and Efficacy of Secret Micro-Needle Fractional RF System® for the Treatment of Facial Wrinkles

Status Active, not recruiting

Clinical Trial Summary

To assess the safety, efficacy and patient satisfaction associated with the treatment of facial wrinkles using the Secret Micro-Needle Fractional RF System® (Ilooda Co., Ltd., Suwon, South Korea).

Clinical Trial Description

Subjects satisfying all inclusion and exclusion criteria will be enrolled in this trial. After baseline evaluation, all subjects will undergo a series of 3 facial treatments with the Secret Micro-Needle Fractional RF System® at 4 week intervals.

Blinded-investigator and subject self-assessments will be performed at Baseline and Days 28, 56, 146, and 180 to evaluate treatment efficacy for facial wrinkling. Of note, the blinded-investigators will be blinded to treatment settings and technique, and number of treatments. Safety will be evaluated by subject diaries, as well as investigator- and subject-rated evaluations of adverse events at all follow-up visits. Mandatory standard 2D digital photography, Canfield VISIA and VECTRA 3D digital photography will be performed at baseline and at each office visit. ;

Related Conditions & MeSH terms

• Aging
• Wrinkle

• NCT number: NCT03426098
• Study type: Interventional
• Source: Goldman, Butterwick, Fitzpatrick and Groff
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 10, 2018
• Completion date: June 30, 2019