Evaluation of Device for Moderate to Severe Cheek Wrinkling

Dr. Suzanne Kilmer is participating in a study involving an investigational device, and you are being asked to participate after careful consideration of the below study description. Please read the included information, and if you would like to participate please contact our office via email, study@skinlasers.com

PURPOSE: To assess the device performance (how well the device works) and the effects of the device on moderate to severe wrinkles in the mid to lower face (below).

The device is considered investigational because it has not been approved for sale by the US FDA.

The device consists of a micro-coring needle (22 gauge) connected to a handle and to a vacuum pump. The repeated insertion of the device in the treatment area results in removal of a small amount of the skin surface.

STUDY PROCEDURES:
The study involves a total of 5 visits and a phone call for a single treatment and a total of 8 visits and a phone call for two treatments. The entire study will last for about 6 months

SCREENING:
There is a screening process that will be completed to determine if you are a good candidate for the study. If you are approved for the study, you will complete and sign an informed consent form to participate.

At the conclusion of the study and full agreed upon participation, you will be paid $50 for every visit you complete.