Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00556946 |
| Other study ID # |
20033286 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 2005 |
| Est. completion date |
October 2014 |
Study information
| Verified date |
October 2022 |
| Source |
University of California, Irvine |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This research study was designed to determine the effect on port wine stains (PWS) of
liposomal benzoporphyrin derivative monoacid (BPD-MA) termed verteporfin by intravenous (IV)
infusion for photodynamic therapy (PDT) or combined PDT and pulsed dye laser (PDL) therapy
(PDT + PDL). The standard treatment for PWS is PDL alone. This lightens some PWS but many
lesions are not completely removed.
PDT uses a medication and light together to cause injury to a target. The medication is given
and then light is directed at the desired area of treatment to achieve an effect. PDT has
been used to treat some skin conditions including pre-cancers and skin cancers. Using PDT or
PDT immediately followed by PDL therapy may improve PWS lightening. At this time, both PDT
and PDT + PDL therapy for treatment of PWS is investigational. The type and amount of
medication and light which may be used to treat PWS is not known, and is likely to be
different than those used for other PDT treatments.
Description:
Procedures will be performed at the Surgery Laser Clinic at the Beckman Laser Institute at
the University of California, Irvine.
At an initial visit, a brief history and physical will be performed.
The history will include: 1) previous treatment to my PWS; 2) current medications; 3) history
of light sensitivity; 4) risk of pregnancy and use of birth control in a female of
child-bearing age.
The physical will include: 1) measurement and evaluation of PWS; 2) measurement of blood
pressure, blood cell count, general chemistries (including liver function tests) and ANA,
which might indicate an increased sensitivity to light.
On the day of treatment, the same brief physical and history will be repeated. A urine
pregnancy test will be performed on females of child-bearing age.
Four circular test sites of PWS will be selected. One test site will receive no treatment.
The second test sites will be treated with the pulsed dye laser at standard setting and
protective eyeglasses to shield the eyes during the laser treatment.
For two additional test spots, the photodynamic therapy (PDT) verteporfin will be
administered intravenously over a 10-minute period. After receiving the verteporfin, the skin
and eyes will be sensitive to light for the next 5 days. The light sensitive protection
precautions will be instructed.
Optical Doppler Tomography unit (ODT) measurements, similar to shining a flash light to PWS
and measuring the light response, which provide information about how blood is flowing
through the PWS.
Photographs and light measurements will be taken during follow-up visits on day 1, day 3, and
1, 2, 4, 8 and 12 weeks after the study treatment. At these visits blood may also be drawn to
check for blood substances that promote blood vessel formation.
At the end of the study, blood tests will be drawn to assess cell count and general
chemistries.
