Dermal Cooling System

Dr. Boey is participating in a new research study. The study is to evaluate a new procedure to lighten benign pigmented lesions on your skin. Benign pigmented lesions may be sun spots, freckles, melasma, moles or café au lait spots. The procedure would be performed by Dr. Boey with an investigational device made available for this study. The procedure would be in our office and you would be here for about 2 hours. During the procedure, small areas of your skin with pigmented lesions will be cooled with the investigational device. Each treated area will be about the size of a postage stamp.

The study would also require that:

• You are willing to have as many as 40 of these cooling areas on your skin.
• You return to our office for several follow-up visits for at least 3 months and maybe as long as 20 months.
• Photographs are taken of the area to be treated before and after the procedure, and at each follow-up visit.
• You avoid sun exposure or use sun protection on the treated areas. If you are interested, there are a now a few things that we need to make sure you don’t have. You must NOT
• have a history of vitiligo, eczema or psoriasis in the treatment area
• have scars or tattoos in the treatment area
  • have a history of melanoma
  • get sick or have a reaction when contacted with or exposed to cold
  • have poor healing of wounds or injury to the skin

If none of these things are true and you are still interested, we’d like to schedule you for a more complete screening. When you come to the screening visit, which should take less than an hour, we will determine if you are eligible for the study. If you are, and you agree to participate, you will be asked to sign an informed consent document. You will then be scheduled for the procedure.

The company sponsoring this research study is also providing modest compensation for the time required for the study procedure and the follow-up visits. We will discuss this further at the screening visit if you are interested in participating.