Port Wine StainsPDT/PDLNCT00556946
Combined Photodynamic and Pulsed Dye Laser Treatment of Port Wine Stains
A study testing Combined Photodynamic & Pulsed Dye Laser Treatment in people with Port Wine Stains, run by University of California, Irvine at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Port Wine Stains
- What is being tested?
- Combined Photodynamic & Pulsed Dye Laser Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Oct 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult 18 years and older
- Have a PWS on an area other than the face
- A negative pregnancy test and non pregnant or nursing
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Beckman Laser Medical Clinic,University
Irvine, California, 02612
About this study
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.
Read the 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.
- Conditions
- Port Wine Stains
- Being tested
- Combined Photodynamic & Pulsed Dye Laser Treatment
- Keywords
- Vascular Malformation
- Medical subject headings
- Hemangioma, Capillary, Vascular Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Photodynamic & Pulsed Dye Laser TreatmentDrug
Treatment of Port Wine Stains using Combined Photodynamic and Pulsed Dye Laser
| Study group | Role | What they receive |
|---|---|---|
| Combined Photodynamic & Pulsed Dye Laser Treatment | Other | Treatment of Port Wine Stains Receives: Drug: Combined Photodynamic & Pulsed Dye Laser Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blanching of Port Wine Stain Birthmark
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2007 (estimated)
- Study startAug 2005
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Port Wine StainsStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Responsible party
- Principal investigator, Beckman Laser Institute and Medical Center, University of California, Irvine
- Investigators
- Kristen Kelly, MD, Principal investigator, Beckman Laser Institute University of California Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00556946
- Sponsor's protocol ID
- 20033286
- Acronym
- PDT/PDL
- Status last verified
- Oct 2022
- First submitted
- 9 Nov 2007
- Last updated
- 21 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Photodynamic and Pulsed Dye Laser Treatment of Port Wine Stains
- ClinicalTrials.gov ID
- NCT00556946
- Acronym / sponsor ID
- PDT/PDL / 20033286
- Conditions
- Port Wine Stains
- Keywords
- Vascular Malformation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Study start
- Aug 2005
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 12 Nov 2007 (estimated)
- Results
- Posted 19 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined Photodynamic & Pulsed Dye Laser Treatment | Other | Drug: Combined Photodynamic & Pulsed Dye Laser TreatmentTreatment of Port Wine Stains |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult 18 years and older
- Have a PWS on an area other than the face
- A negative pregnancy test and non pregnant or nursing
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined Photodynamic & Pulsed Dye Laser TreatmentTreatment of Port Wine Stains using Combined Photodynamic and Pulsed Dye Laser | Drug | Combined Photodynamic & Pulsed Dye Laser Treatment |
Primary outcome
Blanching of Port Wine Stain Birthmark
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristen Kelly, MD principal investigator
Beckman Laser Institute University of California Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Photodynamic & Pulsed Dye Laser Treatment in people with Port Wine Stains, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blanching of Port Wine Stain Birthmark (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2022.