Port Wine StainPhase 1NCT00830466
A Randomized Trial to Study Combined Pulsed Dye Laser and Rapamycin Treatment of Port Wine Stain Birthmarks.
A Phase 1 study testing Laser and rapamycin versus laser alone in people with Port Wine Stain, run by University of California, Irvine at 1 site in United States.
Trial summary
The researchers want to collect data on safety and efficacy of combined pulsed dye laser and rapamycin to improve fading/blanching of port wine stain birthmarks as compared to pulsed dye laser alone, which is the current standard of care. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Port Wine Stain
- What is being tested?
- Laser and rapamycin versus laser alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Jan 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Port wine stain suitable for comparison testing.
- Age > 13 years of age or older; minor will be accompanied in the room by parents or guardians during laser treatment.
- Apparent good health as documented by medical history.
- Ability to understand and carry out subject instructions.
- Women of childbearing potential must have a negative urinary pregnancy test prior to being started on rapamycin.
- Women of child bearing potential must agree to use a medically acceptable method of contraception throughout the study and for 3 months following discontinuation of rapamycin.
Who cannot join
- Inability to understand and carry out instructions.
- Pregnancy.
- Abnormal blood or urine tests
- History of cancer.
- History of high cholesterol, lipids or liver disease.
- Allergy to macrolide drugs (e.g., erythromycin).
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- Any therapy within the previous two months to the proposed port wine stain treatment sites.
- Current participation in any other investigational drug evaluation.
- Concurrent use of known photosensitizing drugs.
- Concurrent use of immunosuppressive drugs or steroids.
- Concurrent use of any of the following medications: antifungals, antiepileptics, protease inhibitors, cimetidine, cisapride, clarithromycin, dannzol, diltiazem, erythromycin, metoclopramide, rifabutin, rifampin, rifapetine, troleandomycin, or verapamil.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beckman Laser Institute and Medical Clinic
Irvine, California, 92612
About this study
The researchers want to collect data on safety and efficacy of combined pulsed dye laser and rapamycin to improve fading/blanching of port wine stain birthmarks as compared to pulsed dye laser alone, which is the current standard of care.
This single center pilot and feasibility study will have a target enrollment of 40 port wine stain subjects at the Beckman Laser Institute and Medical Clinic, University of California, Irvine.
Read the detailed description
The study will offer two different approaches to the treatment of port wine stain birthmarks.
Study Group Number 1: Port wine stain treated by the pulsed dye laser alone, which is the current standard of care: 20 subjects.
Study Group Number 2: Port wine stain treated by combined pulsed dye laser and rapamycin: 20 subjects.
The researchers want to collect data on safety and efficacy of combined pulsed dye laser and rapamycin to improve fading/blanching of port wine stain birthmarks as compared to pulsed dye laser alone, which is the current standard of care. Twenty subjects will have their entire port wine stain birthmark treated by pulsed dye laser alone. Twenty subjects will have their entire port wine stain birthmark treated by combined pulsed dye laser and rapamycin, which is a drug that prevents the formation of blood vessels in the skin. Safety will be evaluated by searching for any local effects such as injury to the skin or systemic effects such as abnormal blood and/or urine studies. Efficacy will be determined by objectively measuring and comparing the port wine stain fading/blanching responses for the two study groups.
- Conditions
- Port Wine Stain
- Being tested
- Laser and rapamycin versus laser alone
- Keywords
- port wine stain
- Medical subject headings
- Port-Wine Stain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser and rapamycin versus laser aloneDrug
Laser and rapamycin versus laser alone
| Study group | Role | What they receive |
|---|---|---|
| Laser and rapamycin versus laser alone | Experimental | Laser and rapamycin versus laser alone Receives: Drug: Laser and rapamycin versus laser alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved port wine stain fading/blanching after laser treatment
Efficacy will be determined by objectively measuring and comparing the port wine stain fading/blanching responses for subjects treated with combined pulsed dye laser and rapamycin versus pulsed dye laser alone
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Port Wine StainStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 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, Pfizer
- Responsible party
- Principal investigator, Beckman Laser Institute and Medical Center, University of California, Irvine
- Investigators
- J. Stuart Nelson, M.D.,Ph.D., Principal investigator, Beckman Laser Institute and Medical Clinic, University of California Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00830466
- Sponsor's protocol ID
- 20086383
- Status last verified
- Oct 2022
- First submitted
- 27 Jan 2009
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial to Study Combined Pulsed Dye Laser and Rapamycin Treatment of Port Wine Stain Birthmarks.
- ClinicalTrials.gov ID
- NCT00830466
- Acronym / sponsor ID
- 20086383
- Conditions
- Port Wine Stain
- Keywords
- port wine stain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine, Pfizer
- Study start
- Dec 2008
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 28 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The researchers want to collect data on safety and efficacy of combined pulsed dye laser and rapamycin to improve fading/blanching of port wine stain birthmarks as compared to pulsed dye laser alone, which is the current standard of care.
This single center pilot and feasibility study will have a target enrollment of 40 port wine stain subjects at the Beckman Laser Institute and Medical Clinic, University of California, Irvine.
Detailed description
The study will offer two different approaches to the treatment of port wine stain birthmarks.
Study Group Number 1: Port wine stain treated by the pulsed dye laser alone, which is the current standard of care: 20 subjects.
Study Group Number 2: Port wine stain treated by combined pulsed dye laser and rapamycin: 20 subjects.
The researchers want to collect data on safety and efficacy of combined pulsed dye laser and rapamycin to improve fading/blanching of port wine stain birthmarks as compared to pulsed dye laser alone, which is the current standard of care. Twenty subjects will have their entire port wine stain birthmark treated by pulsed dye laser alone. Twenty subjects will have their entire port wine stain birthmark treated by combined pulsed dye laser and rapamycin, which is a drug that prevents the formation of blood vessels in the skin. Safety will be evaluated by searching for any local effects such as injury to the skin or systemic effects such as abnormal blood and/or urine studies. Efficacy will be determined by objectively measuring and comparing the port wine stain fading/blanching responses for the two study groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laser and rapamycin versus laser alone | Experimental | Drug: Laser and rapamycin versus laser aloneLaser and rapamycin versus laser alone |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Port wine stain suitable for comparison testing.
- Age > 13 years of age or older; minor will be accompanied in the room by parents or guardians during laser treatment.
- Apparent good health as documented by medical history.
- Ability to understand and carry out subject instructions.
- Women of childbearing potential must have a negative urinary pregnancy test prior to being started on rapamycin.
Key exclusion criteria (11 listed)
- Inability to understand and carry out instructions.
- Pregnancy.
- Abnormal blood or urine tests
- History of cancer.
- History of high cholesterol, lipids or liver 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 |
|---|---|---|
| Laser and rapamycin versus laser aloneLaser and rapamycin versus laser alone | Drug | Laser and rapamycin versus laser alone |
Primary outcome
Improved port wine stain fading/blanching after laser treatment
Time frame: 24 weeks
Efficacy will be determined by objectively measuring and comparing the port wine stain fading/blanching responses for subjects treated with combined pulsed dye laser and rapamycin versus pulsed dye laser alone
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Individual participant dataSharing planned: Undecided
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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.
J. Stuart Nelson, M.D.,Ph.D. principal investigator
Beckman Laser Institute and Medical Clinic, 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 Phase 1 study testing Laser and rapamycin versus laser alone in people with Port Wine Stain, 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 6 inclusion and 11 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 1 Nov 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improved port wine stain fading/blanching after laser treatment (time frame: 24 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 1 Nov 2022.