Silk Medical Aesthetics' Inc. device, SMA-001, is currently under development as a dermal filler to fill wrinkles and folds. This study is designed to collect short-term visual, photographic, and histological and safety data on small aliquots of the product as part of device development. It is an open label study involving up to three investigational sites and a maximum enrollment of 10 subjects. Juvéderm Ultra Plus XC, an FDA-approved dermal filler will serve as a control device. Briefly, the investigational product and the control device will be injected into the abdomen of patients intending to undergo abdominoplasty at a later date. The patients will be followed for 30 days post injection through visual observation. At 30 days post injection, the injected gel and associated tissue will be removed via biopsy during the abdominoplasty surgery and histology slides created for analysis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
13
Intra-dermal injection of SMA-001 and control device.
Skincare Physicians, Inc
Chestnut Hill, Massachusetts, United States
Gryskiewicz Twin Cities Cosmetic Surgery
Burnsville, Minnesota, United States
Jewell Plastic Surgery
Eugene, Oregon, United States
Histological performance
Four week histology data
Time frame: 4 weeks
Safety
Safety of the device through Adverse Event tracking
Time frame: 4 weeks
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