Port Wine StainPhase 1NCT00580736
Optical Clearing of the Skin in Conjunction With Laser Treatments
A Phase 1 study testing Optical Clearing in people with Port Wine Stain and Nevus of Ota, run by University of California, Irvine at 1 site in United States.
Trial summary
The research hypothesis is that topical application of a mixture of pre-polymers of polypropylene glycol and polyethylene glycol (an optical clearing agent) will reduce skin light scattering, increasing the amount of light reaching the target for diagnostic as well as therapeutic purposes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Port Wine Stain, Nevus of Ota, Tattoos
- What is being tested?
- Optical Clearing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Jul 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult 18 years and older
- Lesion diagnoses in an area measuring 3 cm2 or more on any body site
- Apparent good health
Who cannot join
- Pregnant women
- History of cutaneous photosensitivity
- History of photodermatoses
Trial locations and contacts
1 site in 1 country.
United States1 site
Beckman Laser Institute Medical and Surgical Clinic
Irvine, California, 92612
About this study
The research hypothesis is that topical application of a mixture of pre-polymers of polypropylene glycol and polyethylene glycol (an optical clearing agent) will reduce skin light scattering, increasing the amount of light reaching the target for diagnostic as well as therapeutic purposes.
Read the detailed description
The researchers expect that application of the optical clearing agent for treatment of benign vascular lesions, tattoos, nevus of Ota, hypertrichosis, scars, acne and sebaceous hyperplasia will result in
- decreased reflectance of the predominant color from the surface of skin (decreased red light scattering in case of benign vascular lesions, etc) as compared to the control group.
- greater Optical Coherence Tomography a non-invasive light based imaging method imaging depth as compared to the control group.
- greater improvement in the treatment outcome (decrease in the erythema index following laser treatment of vascular lesions as compared to the laser alone group; improved lightening of the tattoo or nevus of Ota as compared to the laser treatment alone group; significant decrease in hair re-growth as compared to laser treatment alone in patients seeking hair removal; greater improvement of scars, acne and sebaceous hyperplasia).
- Conditions
- Port Wine Stain, Nevus of Ota, Tattoos, Scars, Acne, Hypertrichosis
- Being tested
- Optical Clearing
- Keywords
- sebaceous hyperplasia
- Medical subject headings
- Port-Wine Stain, Nevus of Ota, Cicatrix, Acne Vulgaris, Hypertrichosis, Sebaceous Gland Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical ClearingDevice
Optical Clearing
| Study group | Role | What they receive |
|---|---|---|
| Optical Clearing | Experimental | Optical Clearing Receives: Device: Optical Clearing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome measure is to evaluate the optical clearing effects of the combination mixture of pre-polymers of polypropylene glycol and polyethylene glycol.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2007 (estimated)
- Study startMar 2004
- Primary completionJul 2008
- Study completionJul 2008
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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 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 M Kelly, M.D, Principal investigator, Beckman Laser Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00580736
- Sponsor's protocol ID
- 20033442
- Status last verified
- Oct 2022
- First submitted
- 18 Dec 2007
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Clearing of the Skin in Conjunction With Laser Treatments
- ClinicalTrials.gov ID
- NCT00580736
- Acronym / sponsor ID
- 20033442
- Conditions
- Port Wine Stain, Nevus of Ota, Tattoos, Scars, Acne, Hypertrichosis
- Keywords
- sebaceous hyperplasia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Study start
- Mar 2004
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 27 Dec 2007 (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 research hypothesis is that topical application of a mixture of pre-polymers of polypropylene glycol and polyethylene glycol (an optical clearing agent) will reduce skin light scattering, increasing the amount of light reaching the target for diagnostic as well as therapeutic purposes.
Detailed description
The researchers expect that application of the optical clearing agent for treatment of benign vascular lesions, tattoos, nevus of Ota, hypertrichosis, scars, acne and sebaceous hyperplasia will result in
- decreased reflectance of the predominant color from the surface of skin (decreased red light scattering in case of benign vascular lesions, etc) as compared to the control group.
- greater Optical Coherence Tomography a non-invasive light based imaging method imaging depth as compared to the control group.
- greater improvement in the treatment outcome (decrease in the erythema index following laser treatment of vascular lesions as compared to the laser alone group; improved lightening of the tattoo or nevus of Ota as compared to the laser treatment alone group; significant decrease in hair re-growth as compared to laser treatment alone in patients seeking hair removal; greater improvement of scars, acne and sebaceous hyperplasia).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Optical Clearing | Experimental | Device: Optical ClearingOptical Clearing |
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
- Lesion diagnoses in an area measuring 3 cm2 or more on any body site
- Apparent good health
Key exclusion criteria (3 listed)
- Pregnant women
- History of cutaneous photosensitivity
- History of photodermatoses
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 |
|---|---|---|
| Optical ClearingOptical Clearing | Device | Optical Clearing |
Primary outcome
Outcome measure is to evaluate the optical clearing effects of the combination mixture of pre-polymers of polypropylene glycol and polyethylene glycol.
Time frame: 8 weeks
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 20 Oct 2022.
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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 M Kelly, M.D principal investigator
Beckman Laser Institute
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 Optical Clearing in people with Port Wine Stain and Nevus of Ota, 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 3 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 20 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.
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?
Outcome measure is to evaluate the optical clearing effects of the combination mixture of pre-polymers of polypropylene glycol and polyethylene glycol. (time frame: 8 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 20 Oct 2022.