The objective of this clinical study is to evaluate the safety and efficacy of mechanical coring for directional skin tightening. This study is a prospective, up to 3 center, multiple skin treatment area study of the safety and efficacy of mechanical coring with directional closure to achieve directional skin tightening.
The study will evaluate the progress of up to 70 subjects after one treatment at up to 6 treatment areas on the body chosen from 2 on the neck (each treatment area approximately 1x3 cm), 2 on each underarm, 1 on each cheek, 2 on the abdomen, one on each thigh and 2 on the forehead area above the eyebrows (all approximately 6x4 cm). Subjects will be followed at 2, 5, 14, 28, 60, and 90 days after treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
VENUS AIME is a micro-coring device of the skin that can potentially help to reduce visible skin scarring, improve skin laxity and reduce wrinkles.
Berman Skin Institute
Los Altos, California, United States
RECRUITINGLe's Aesthetics
San Jose, California, United States
RECRUITINGDeNova Research
Chicago, Illinois, United States
COMPLETEDPercentage of Cores Successfully Removed by Coring Device
Percentage of cores successfully removed by the coring device without manual removal.
Time frame: 1 day
Downtime, as evaluated using the Subject Questionnaire
Made of 8 questions asking if subject felt self-conscious, covered up the treatment area, avoided people, unable to perform normal activities, felt pain, discomfort or itchiness. For each, the subject may answer 1) Not at all, 2) Some of the time, or 3) Most of the time. A lower score indicates a better result.
Time frame: Up to Day 90 (end of study)
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