To evaluate the safety, and efficacy of the ASR device for the temporary improvement in the appearance of a keloids.
To evaluate the safety, and efficacy of the ASR device for the temporary improvement in the appearance of a keloids. To demonstrate improvement in the keloid scars, without unexpected adverse events (UAEs) and serious adverse events (SAEs) directly attributable to the ASR device or treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
9
Treatment of keloid scars for the temporary improvement in appearance.
Clear Dermatology and Aesthetics Center
Scottsdale, Arizona, United States
Procedure Safety
The safety endpoint will be met if all treated participants are free from unexpected adverse events and serious adverse events directly attributable to the ASR device or treatment.
Time frame: 12 weeks
Treatement Tolerability
ASR treatment tolerability will be met if the average pain measure using a 0-10 pain scale across all treated Participants is \< 8.0.
Time frame: 12 weeks
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