A total of at least 15 and up to 17 healthy subjects at a single site, aged 25-45 years old, who wish to receive a lifting effect and improved muscle definition, will be included in the study. The procedure will include treatments with the Legend Pro™ DMA™ technology. Photos will be obtained at pre-defined time points throughout the study.
Single center, prospective, open Label with Before \& After Study Design. This study is designed to evaluate the immediate efficacy and safety of Legend Pro™'s DMA™ muscle stimulation technology. Treatment areas will include the face, buttocks, or abdominal region. Each subject will receive 1 treatment with no follow-up visits required. Interim assessment will be held after half of the study population has received treatment. The study population will be divided into three arms as follows: * 5 female subjects will receive treatment in the face area * 5 female subjects will receive treatment in the buttocks area * 5 male subjects will receive treatment in the abdominal region
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Each arm will receive the DMA treatment in a specific area on the body to observe immediate effect.
Dermatology, Laser, and Vein Specialists of the Carolinas, PLLC
Charlotte, North Carolina, United States
To evaluate the immediate effects and safety of DMATM novel muscle stimulation technology on the face, buttocks, and abdominal regions: GAI scale
Efficacy of the treatment will be based on before and after photography. Efficacy will be established by the Global Aesthetic Improvement scale (GAI) completed by the Principal investigator. Success is defined as an improvement of at least 1 point on the GAI scale assessed by the investigator, as compared to baseline. Global Aesthetic Improvement (GAI) Scale: Worse (0), No change (1), Somewhat improved (2), Moderately improved (3), Very Much Improved (4)
Time frame: 6 months
To evaluate procedure-related skin safety, subject discomfort, and subject satisfaction: questionnaire
The secondary endpoint will be assessed by the following: • Subject satisfaction questionnaire Safety End-Points: * Immediate skin response (erythema, edema, etc.) following each treatment as evaluated by the investigator. * Subject assessment of pain and discomfort associated with treatments using a Pain Visual Analogue Scale (VAS), were 0 is "no pain" and 10 is "intolerable pain" * Skin safety throughout the study as determined by the investigator by examining the post-treatment occurrences of complications and adverse events.
Time frame: 6 months
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