Combined Photodynamic and Pulsed Dye Laser Treatment of Port Wine Stains - Full Text View

Sponsors and Collaborators:	University of California, Irvine Beckman Laser Institute University of California Irvine QLT Inc
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00556946

Purpose

This research study was designed to determine the effect on port wine stains (PWS) of liposomal benzoporphyrin derivative monoacid (BPD-MA) termed verteporfin (distributed for medical indications as Visudyne by QLT, Inc., Vancouver, Canada) 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.

Condition	Intervention	Phase
Port Wine Stains	Procedure: Combine photodynamic therapy and pulsed dye laser	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title:	Combined Photodynamic and Pulsed Dye Laser Treatment of Port Wine Stains

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:

Combined sub-threshold photodynamic and pulsed dye laser therapy can be used to safely achieve improved PWS lesion lightening as compared to either sub-threshold photodynamic therapy or pulsed dye laser therapy alone [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	August 2005
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Four circular test sites with a 2 cm diameter will be delineated using a yellow high lighter marker. The first test site will be a control and receive no treatment. The second test site will be treated with the pulsed dye laser at standard parameters.	Procedure: Combine photodynamic therapy and pulsed dye laser Verteporfin IV for phototherapy

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00556946

Locations

United States, California
Beckman Laser Medical Clinic,University
Irvine, California, United States, 02612

Sponsors and Collaborators

University of California, Irvine

Beckman Laser Institute University of California Irvine

QLT Inc

Investigators

Principal Investigator:

Kristen Kelly, MD

Beckman Laser Institute University of California Irvine

More Information

No publications provided

Responsible Party:	Beckman Laser Institute ( Kristen Kelly, M.D. )
Study ID Numbers:	AR-51443; PHS-NIH, P41-RR01192;NIH-LAMMP
Study First Received:	November 9, 2007
Last Updated:	March 12, 2009
ClinicalTrials.gov Identifier:	NCT00556946 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Irvine:

Vascular Malformation

Study placed in the following topic categories:

Skin Diseases
Nevi Flammei, Familial Multiple
Port-Wine Stain
Vascular Malformations

Verteporfin
Skin Abnormalities
Congenital Abnormalities

Additional relevant MeSH terms:

Skin Diseases
Port-Wine Stain
Skin Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on July 02, 2009