Port-Wine Stain
Conditions
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.
Interventions
DEVICEPulsed Dye Laser
port wine stain
DEVICECombined Bipolar Radiofrequency&Pulsed Dye Laser
Combined Bipolar Radiofrequency&Pulsed Dye Laser Treatment
Sponsors
Candela Corporation
Beckman Laser Institute University of California Irvine
University of California, Irvine
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Combined Radio Frequency and Pulsed Dye Laser Treatment 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. | 22 |
| Total | 22 |
Baseline characteristics
| Characteristic | Combined Radio Frequency and Pulsed Dye Laser Treatment |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 |
Outcome results
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.
Time frame: 8 weeks
Population: Each subject received both treatments on their corresponding test sites. We compared response of test sites to different treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulsed Dye Laser Only Treatment | Percent Change in Blanching of Port Wine Stain | 6 percentage | Standard Deviation 8 |
| Combined Radio Frequency and Pulsed Dye Laser Treatment | Percent Change in Blanching of Port Wine Stain | 5 percentage | Standard Deviation 12 |