Combined Bipolar Radiofrequency&Pulsed Dye Laser Treatment

Port-Wine Stain Clinical Trial

Official title:

Combined Bipolar Radiofrequency and Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01775722
• Other study ID #: 20129092
• Status: Completed
• Phase: N/A
• Start date: December 2012
• Est. completion date: August 2015

Study information

• Verified date: October 2022
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemangioma, Capillary
• Port-Wine Stain

Intervention

Device:
• Pulsed Dye Laser
port wine stain
• Combined Bipolar Radiofrequency&Pulsed Dye Laser
Combined Bipolar Radiofrequency&Pulsed Dye Laser Treatment

Locations

Country	Name	City	State
United States	Beckman Laser Institute Medical Clinic	Irvine	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Irvine	Beckman Laser Institute University of California Irvine, Candela Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in Blanching of Port Wine Stain	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.	8 weeks