Port Wine Stain
Conditions
Keywords
Birthmark, PWS
Brief summary
The researcher want to improve port wine stain (PWS) therapeutic outcome in response to laser therapy. The researcher want to determine whether the combined use of pulsed dye laser (PDL) therapy and topical tacrolimus or pimecrolimus will improve PWS therapeutic outcome.
Detailed description
Both topical agents inhibit nuclear factor of activated T-cells (NFAT) which blocks the calcineurin/NFAT pathway inhibiting endothelial cell proliferation and angiogenesis, which could be very useful in preventing PWS recanalization. The combined use of PDL to induce PWS blood vessel injury, and topical antiangiogenic agents to prevent PWS blood vessel angiogenesis and recanalization after laser therapy, will improve PWS lesion blanching.
Interventions
DRUGTopical Antiangiogenic
Topical Antiangiogenic
DEVICEPulsed Dye Laser
Pulsed Dye Laser
Sponsors
Beckman Laser Institute University of California Irvine
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 16 years of age and older * Have PWS suitable for comparison testing as determined by the study doctor
Exclusion criteria
* Less than 16 years old * Are pregnant * Have skin cancer * Currently taking immunosuppressive or steroids or photosensitizing drugs * Current participation in any other investigational drug evaluation * Concurrent use of known photosensitizing drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improve PWS lesion blanching. | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| To determine whether the combined use of pulsed dye laser (PDL) therapy and topical agent will improve PWS outcome. | 8 weeks |
Outcome results
None listed