N/A
N=17
Combined Photodynamic and Pulsed Dye Laser Treatment of Port Wine Stains
Port Wine Stains
Bottom Line
View on ClinicalTrials.gov: NCT00556946 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: Blanching of Port Wine Stain Birthmark — 16 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Combined Photodynamic & Pulsed Dye Laser Treatment (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Irvine
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blanching of Port Wine Stain Birthmark |
16 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Adult 18 years and older
- Have a PWS on an area other than the face
- A negative pregnancy test and non pregnant or nursing
Exclusion Criteria
- Under 18 years of age
- Have an allergy to verteporfin, porfimer sodium or other porphyrins
- Have a history of porphyria (a disease that can cause sensitivity to light)
- Have had treatment to the PWS test sites in the last 8 weeks
- Have an active uncontrolled infection or other significant disease
- Currently using medications that cause sensitivity to light such as tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics and griseofulvin
- Currently using medications that increase bleeding, including aspirin, coumadin or non-steroidal anti-inflammatory drugs
- Have very dark skin which is sensitive to laser treatment
- Have a positive ANA (lab tests which indicates sensitivity to light)
Data sourced from ClinicalTrials.gov (NCT00556946). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.