Treatment of Vascular Lesions With a Tandem 532/1064 nm Laser

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00585338
First received: December 18, 2007
Last updated: December 26, 2012
Last verified: December 2012

December 18, 2007
December 26, 2012
December 2007
October 2010   (final data collection date for primary outcome measure)
demonstrate vascular lesions blanching with no or only mild AE(hyperpigmentation) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00585338 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Treatment of Vascular Lesions With a Tandem 532/1064 nm Laser
Treatment of Vascular Lesions With a Tandem 532/1064 nm Laser

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.

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Vascular Lesion
Other: Treatment of Vascular Lesions With a Tandem 532/1064 nm Laser
Treatment of Vascular Lesions With a Tandem 532/1064 nm Laser
Other Name: Tandem 532/1064 nm Laser
Treatment of Vascular Lesions
Treatment of Vascular LesionsWith a Tandem 532/1064 nm Laser
Intervention: Other: Treatment of Vascular Lesions With a Tandem 532/1064 nm Laser
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1
October 2010
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult age 18 years and older
  • Diagnosis of vascular lesion

Exclusion Criteria:

  • Age <18
  • Pregnancy
  • History of cutaneous photosensitivity
  • Any therapy to the proposed treatment sites within the previous two months
  • Current participation in any other investigational drug or device evaluation
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00585338
ASLMS-41746; SWF-43653
No
Montana Compton, University of California, Irvine
Montana Compton
Not Provided
Study Director: John S Nelson, M.D, PhD Beckman Laser Institute University of California Irvine
Principal Investigator: Wangcun Jia, PhD Beckman Laser Institute University of California Irvine
University of California, Irvine
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP