Combined Photodynamic and Pulsed Dye Laser Treatment of Port Wine Stains

NCT00556946 | Completed Results DMC

• 1 other identifier: 20033286
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Port Wine Stains

Keywords

Vascular Malformation

Outcome Measures

Primary Outcomes (1)

• Blanching of Port Wine Stain Birthmark

  12 weeks

Study Arms (1)

Combined Photodynamic & Pulsed Dye Laser Treatment

OTHER

Treatment of Port Wine Stains

Drug: Combined Photodynamic & Pulsed Dye Laser Treatment

Interventions

Combined Photodynamic & Pulsed Dye Laser Treatment DRUG

Treatment of Port Wine Stains using Combined Photodynamic and Pulsed Dye Laser

Combined Photodynamic & Pulsed Dye Laser Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult 18 years and older
• Have a PWS on an area other than the face
• A negative pregnancy test and non pregnant or nursing

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, Irvine: lead
• Beckman Laser Institute University of California Irvine: collaborator

Study Sites (1)

Beckman Laser Medical Clinic,University

Irvine, California, 02612, United States

Location

MeSH Terms

Conditions

Hemangioma, Capillary; Vascular Malformations

Condition Hierarchy (Ancestors)

Hemangioma; Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms; Cardiovascular Abnormalities; Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Kristen M. Kelly, M.D.
• Organization: University of California, Irvine

kmkelly@uci.edu

949-824-7103

Study Officials

• Kristen Kelly, MD

  Beckman Laser Institute University of California Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kristen Kelly, M.D., Professor of Dermatology and Surgery

Study Record Dates

• First Submitted: November 9, 2007
• First Posted: November 12, 2007
• Study Start: August 1, 2005
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 21, 2022
• Results First Posted: April 19, 2016

Record last verified: 2022-10

Locations

US (1)