Combined Bipolar Radiofrequency&Pulsed Dye Laser Treatment

University of California Irvine (UCI) logo

University of California Irvine (UCI)

Status

Completed

Conditions

Port-Wine Stain

Treatments

Device: Pulsed Dye Laser
Device: Combined Bipolar Radiofrequency&Pulsed Dye Laser

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01775722
20129092

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

22 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy 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

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

22 participants in 2 patient groups

Pulsed Dye Laser
Other group
Description:
port wine stain treatment using Pulse Dye Laser
Treatment:
Device: Pulsed Dye Laser
Bipolar Radiofrequency&Pulsed Dye Laser
Experimental group
Description:
Port wine stain using Combined Bipolar Radiofrequency&Pulsed Dye Laser
Treatment:
Device: Combined Bipolar Radiofrequency&Pulsed Dye Laser

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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