A prospective, interventional, single-arm study to evaluate histologic changes in skin following cryotherapy with the study device.
This study is to include healthy adults who intend to undergo an abdominoplasty surgery, and agree to have small areas of their middle and lower abdomen exposed to cooling with the Dermal Cooling System within 180 days before the planned surgery. Exposure of multiple test sites will be completed in areas of skin that will be excised as part of the abdominoplasty procedure. Clinical assessments of the treatment sites at 1-week post-treatment and at 1-month post-treatment intervals throughout the time period prior to surgical excision, and histologic evaluation of the treated skin will be conducted to assess skin changes.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Treatment with dermal cooling system.
Kaufman Plastic Surgery
Folsom, California, United States
Fremont Plastic Surgery
Fremont, California, United States
Histologic evaluation of treated skin
Identify a range of treatment parameters which elicits a response in melanocytes based upon histologic assessments.
Time frame: 1-180 days
Access device or procedure-related adverse events
Assess adverse events and side effects.
Time frame: 1 - 180 days
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