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| Descriptive Information Fields | |||||
| Brief Title † | Treatment of Vascular Lesions With a Tandem 532/1064 nm Laser | ||||
| Official Title † | Treatment of Vascular Lesions With a Tandem 532/1064 nm Laser | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase I | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | demonstrate vascular lesions blanching with no or only mild AE(hyperpigmentation) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] | ||||
| Secondary Outcome Measure † | |||||
| Condition † | Vascular Lesion | ||||
| Intervention † | Device: tandem laser | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 10 | ||||
| Start Date † | December 2007 | ||||
| Completion Date | July 2012 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00585338 | ||||
| Organization ID | GM-8620:PHS-NIH | ||||
| Secondary IDs †† | P41-RR01192;NIH-LAMMP | ||||
| Study Sponsor † | University of California, Irvine | ||||
| Collaborators †† | Tandem Laser, Fotona | ||||
| Investigators † |
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| Information Provided By | University of California, Irvine | ||||
| Verification Date | March 2008 | ||||
| First Received Date † | December 18, 2007 | ||||
| Last Updated Date | March 26, 2008 | ||||
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