The purpose of this study is to evaluate whether the Dermal Cooling System can be used to elicit an improvement in the cosmetic appearance or physical symptoms of common skin conditions.
This is a prospective, non-randomized, open-label study to evaluate the effectiveness of the Dermal Cooling system to determine if cosmetic benefits or physical symptoms are achieved in common skin conditions.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
88
Controlled localized cooling may be applied to lesions using the Dermal Cooling System.
West Coast Research
Dublin, California, United States
Oak Dermatology
Naperville, Illinois, United States
Skin Search of Rochester, Inc.
Rochester, New York, United States
Dermatology, Laser and Vein Specialists of the Carolinas
Charlotte, North Carolina, United States
Change in appearance in the treated area as determined by the Physician Global Assessment (PGA).
Investigator assessment using Physician Global Assessment (PGA); graded from "4" (very much improved") to "0" (worse).
Time frame: up to 3 months
Incidence of treatment-emergent adverse events
The safety of the treatment is determined by the incidence of device- or procedure-related serious adverse events.
Time frame: Up to 12 months
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