Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of California, Irvine
With
Candela Corporation
Beckman Laser Institute University of California Irvine
The researcher want to use the combination of radiofrequency electrical energy with pulsed dye laser light energy which can improve therapeutic outcome of Port wine stain Birthmark. This investigational device is essentially a combination of two commercially available systems cleared for marketing (K044351 and K052324) provided by Candela Laser Corporation.
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Port Wine Stain suitable for comparison testing
2. Age \> 12 years of age; minor will be accompanied in the room by parents or guardians during laser treatment
3. Apparent good health as documented by medical history
4. Ability to understand and carry out subject instructions
You may not be if
1. History of photodermatoses or skin cancer
2. Any therapy within the previous two months to the proposed port wine stain treatment sites
3. Current participation in any other investigational drug or device evaluation
4. Concurrent use of known photosensitizing drugs
5. Inability to understand and carry out instructions
