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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
A series of 3 facial treatments with the Secret Micro-Needle Fractional RF System® at 4 week intervals.
West Dermatology Research Center
San Diego, California, United States
Wrinkles
Improvement in Wrinkles Based on the Fitzpatrick Wrinkle Scale
Time frame: Baseline to Day 146
Rating of Non-Sequential Images
Ratings of non-sequential images of subjects at baseline, Day 28, and Day 56. Improvement is defined as a minimum improvement by a score of 1 on the Fitzpatrick Wrinkle Scale or Modified Fitzpatrick Wrinkle Scale as graded by two out of three blinded evaluators, who will be blinded to treatment settings and technique, and number of treatments
Time frame: Baseline, Day 28, and Day 56.
Global Aesthetic Improvement Score
Investigator Assessed Global Aesthetic Improvement Score
Time frame: Baseline to Day 28, 56, and 146
Subject Satisfaction
Subject-assessed Satisfaction with Facial Appearance scale (FACE-Q)
Time frame: Baseline to Day 28, 56, and 146
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