Port Wine Stain
Conditions
Keywords
Diagnosis, Port Wine Stain, PWS
Brief summary
Lasers are being used to treat Port Wine Stains (PWS), but the laser doesn't always work. Only about 10% of PWS can be completely cleared. The research team believes that the investigators can improve the response of PWS to laser therapy by using a computer program that the principal investigator of this study (Dr. Shafirstein PhD) has developed. The purpose of this study is to test the validity of this computer program. Personalized Interactive Laser Therapy (PILT) could significantly improve clinical outcomes of laser treatment of PWS.
Interventions
DEVICEThermoVision A20M Infrared Camera
FLIR Systems, Boston, MA. This is a non invasive passive thermal imaging device with less than minimal risk to subjects and staff.
DEVICEScleroPLUS
Sclerolaser, Candela Corp., Wayland, MA. This laser is approved by the food and drug administration (FDA) for treating PWS lesions and will be used as labeled.
DEVICE3D Digital Camera
3dMD, Atlanta, GA. Approved by the food and drug administration (FDA) for imaging patients and will be used as labeled.
Sponsors
Arkansas Children's Hospital Research Institute
Children's University Medical Group
University of Arkansas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to 17 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with a PWS * At least one visible PWS measuring greater than or equal to 15 mm in diameter. * Information provided regarding alternative treatment methods, includig no treatment. * Reading, understanding, and signing of an informed consent document. * Children age 7 years or older has read, understood, and signed an assent document. * Agreement to participate in the study. * Agreement to return to at least 1 follow-up evaluation and treatment within 1 year after first treatment. * Zubrod performance status of 0 or 1 at screening.
Exclusion criteria
* Inability or unwillingness of subject to participate in the study. * Inability or unwillingness of one parent or legal guardian of the subject to sign written informed consent document. * Subject can not return to at least 1 follow-up visit within 1 year, after the first treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Laser Setting to be Used to Treat Port Wine Stains as Measured by Mathematical Calculations Based on Imaging and Temperature Analysis of Malformation. | Three treatments up to one year, whichever is first | 6 subjects were enrolled but no data was ever collected due to early termination of the study due to the PI's relocation. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Overall Study Group | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Early Termination of Protocol - PI Reloc | 6 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Average Laser Setting to be Used to Treat Port Wine Stains as Measured by Mathematical Calculations Based on Imaging and Temperature Analysis of Malformation.
6 subjects were enrolled but no data was ever collected due to early termination of the study due to the PI's relocation.
Time frame: Three treatments up to one year, whichever is first
Population: 6 subjects were enrolled but no data was ever collected due to early termination of the study due to the PI's relocation.