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| Sponsors and Collaborators: |
University of California, Irvine Tandem Laser, Fotona |
| Information provided by: | University of California, Irvine |
| ClinicalTrials.gov Identifier: | NCT00585338 |
Purpose
Dermatologists have for many years treated vascular lesions by a variety of modalities including cryosurgery, electrotherapy, dermabrasion and radiation.
It has been hypothesized that simultaneous delivery of these two wavelengths may provide safer, and in some cases more effective, vascular lesion removal.
The Tandem laser is capable of emitting multiple cryogen spurts intermittently with multiple 532/1064 nm laser pulses (MCS-MLP). This mode may reduce malformed blood vessels with a low incidence of long-term side effects.
The purpose of this pilot study will be to determine if the Tandem 532/1064 nm laser can achieve blanching of vascular lesions such as facial telangiectasia, leg veins, PWS.
| Condition | Intervention | Phase |
|
Vascular Lesion |
Device: tandem laser |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Treatment of Vascular Lesions With a Tandem 532/1064 nm Laser |
| Estimated Enrollment: | 10 |
| Study Start Date: | December 2007 |
| 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 |
Device: tandem laser
tandem 532/1064 nm laser
|
Efficacy will be assessed by determining blanching of vascular lesions after treatment. The researcher' will be monitoring for any other adverse effects which may be associated with this laser including scarring, hypopigmentation, ulceration or an other unexpected effect.
Subjects with darker skin types will be at higher risk for adverse effects and treatment parameters will be chosen appropriately to minimize any increase in risk. This device does have cryogen spray cooling which protects the epidermis and decreases the risk of adverse effects in darker skin types.
One to four test sites will be chosen. On each site 1-10 pulses will be performed. Different laser parameters may be used for each test site. The subject will return for evaluation of the test sites at 6-12 weeks.
At the follow-up evaluation, the period of bruising will be evaluated and lesion blanching will be graded. Test areas will also be evaluated for adverse effects.
Parameters of the test area with the greatest degree of blanching without adverse effects will be utilized for further treatment. If no test area is determined to have blanching without adverse effects, further test sites may be performed.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |||||
| Beckman Laser Institute Medical and Surgical Clinic | |||||
| IRVINE, California, United States, 92612 | |||||
| University of California, Irvine |
| Tandem Laser, Fotona |
| Study Chair: | JOHN S NELSON, M.D | BECKMAN LASER INSTITUTE |
More Information
| Responsible Party: | Beckman Laser Institute ( J.Stuart Nelson, M.D.,Ph.D ) |
| Study ID Numbers: | GM-8620:PHS-NIH, P41-RR01192;NIH-LAMMP |
| First Received: | December 18, 2007 |
| Last Updated: | July 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00585338 |
| Health Authority: | United States: Institutional Review Board |
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