Combined Bipolar Radiofrequency&Pulsed Dye Laser Treatment
Status
Conditions
Treatments
Details and patient eligibility
About
Port wine stain Birthmark is a congenital, progressive vascular malformation of human skin. However, even though the pulsed dye laser is considered as the treatment of choice for Port wine stain Birthmark the degree of fading can remain variable and unpredictable after laser treatment.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Port Wine Stain suitable for comparison testing
- Age > 12 years of age; minor will be accompanied in the room by parents or guardians during laser treatment
- Apparent good health as documented by medical history
- Ability to understand and carry out subject instructions
Exclusion criteria
- History of photodermatoses or skin cancer
- Any therapy within the previous two months to the proposed port wine stain treatment sites
- Current participation in any other investigational drug or device evaluation
- Concurrent use of known photosensitizing drugs
- Inability to understand and carry out instructions
Trial design
Primary purpose
Allocation
Interventional model
Masking
22 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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