Combined Bipolar Radiofrequency&Pulsed Dye Laser Treatment

Not Applicable

Completed

• Conditions: Port-Wine Stain
• Interventions: Device: Combined Bipolar Radiofrequency&Pulsed Dye Laser; Device: Pulsed Dye Laser

• Registration Number: NCT01775722
• Lead Sponsor: University of California, Irvine

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-01-14
• Study First Submitted QC: 2013-01-22
• Study First Posted: 2013-01-25
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Results First Submitted: 2015-08-27
• Results First Submitted QC: 2018-03-09
• Results First Posted: 2018-04-09
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-28
• Last Update Posted: 2022-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bipolar Radiofrequency&Pulsed Dye Laser	Combined Bipolar Radiofrequency&Pulsed Dye Laser	Port wine stain using Combined Bipolar Radiofrequency\&Pulsed Dye Laser
Pulsed Dye Laser	Pulsed Dye Laser	port wine stain treatment using Pulse Dye Laser

Primary Outcome Measures

Name	Time	Method
Percent Change in Blanching of Port Wine Stain	8 weeks	Port Wine Stain blood volume fractions in the skin before (fB1), and 8 weeks after (fB2) treatment will be determined using the corresponding visual reflectance spectra measured at the treatment sites. The primary outcome, degree of blanching, B, is computed as B = (fB1-fB2)/fB1.

Trial Locations

Locations (1)

Beckman Laser Institute Medical Clinic; 🇺🇸 Irvine, California, United States