Trial Outcomes & Findings for Combined Bipolar Radiofrequency&Pulsed Dye Laser Treatment (NCT NCT01775722)

NCT ID: NCT01775722

Last Updated: 2022-11-02

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 22 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2022-11-02

Participant Flow

Unit of analysis: Test Site

Participant milestones

Measure	Combined Radio Frequency and Pulsed Dye Laser Treatment This is a within-participant design due to the response of port wine stain to laser therapy varies greatly from patient to patient. Pulsed dye laser only test site and combined radio frequency and pulsed dye laser test site were placed side by side on each subject's port wine stain area. Thus the differences among subjects will be explicitly accounted for and removed from the error component when assessing treatment effects.
Overall Study STARTED	22 44
Overall Study COMPLETED	20 40
Overall Study NOT COMPLETED	2 4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Combined Bipolar Radiofrequency&Pulsed Dye Laser Treatment

Baseline characteristics by cohort

Measure	Combined Radio Frequency and Pulsed Dye Laser Treatment n=22 Participants There are two test sites on each Port Wine Stain, one test site was treated with Pulsed dye laser only, and another test site was treated with combined radio frequency and pulsed dye laser. Two test sites were placed side by side randomly on each subject's port wine stain area.
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Each subject received both treatments on their corresponding test sites. We compared response of test sites to different treatment.

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.

Outcome measures

Measure	Pulsed Dye Laser Only Treatment n=20 Test site Measurement on the test site treated with Pulsed Dye Laser only.	Combined Radio Frequency and Pulsed Dye Laser Treatment n=20 Test site Measurement on test sites treated with combined Radio Frequency and Pulsed Dye Laser.
Percent Change in Blanching of Port Wine Stain	6 percentage Standard Deviation 8	5 percentage Standard Deviation 12

Adverse Events

Pulsed Dye Laser Only Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Combined Radio Frequency and Pulsed Dye Laser Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

J Stuart Nelson

University of California, Irvine. Beckamn Laser Institute

Phone: 9498247997

Email: jsnelson@uci.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place