NCT03426098

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

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: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Goldman, Butterwick, Fitzpatrick and Groff · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

• Aging
• Wrinkle

Interventions

Type	Name	Description
DEVICE	Secret RF	A series of 3 facial treatments with the Secret Micro-Needle Fractional RF System® at 4 week intervals.

Timeline

• Start date: 2018-02-10
• Primary completion: 2019-05-30
• Completion: 2019-06-30
• First posted: 2018-02-08
• Last updated: 2019-05-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study