NCT01362192

Treatment of Lower Extremity Spider Veins With Excel V

A Clinical Evaluation of the Treatment of Lower Extremity Spider Veins Using a Dual Wavelength Laser Emitting 532 nm and 1064 nm Laser Energy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Cutera Inc. · Industry
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and effectiveness of a new laser for the removal of unsightly spider veins on the legs. The device used in this study is the Cutera Excel V laser, which is a dual wavelength 532 nm potassium titanyl phosphate (KTP) and 1064 nm neodymium-doped yttrium aluminum garnet (Nd:YAG) laser. The Excel V laser has received 510(k) clearance from the FDA, which means the FDA has approved the laser for dermatological and vascular conditions, like spider veins.

Detailed description

Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins in at least 2, and up to 4, separate areas. Subjects will receive 2 laser treatments spaced 12 weeks apart. Subjects will be followed for 24 weeks (12 weeks after the final laser treatment). Efficacy will be evaluated by blinded independent physician assessment of improvement in treated spider veins using digital photographs taken at baseline and the final follow-up visit by a third-party medical photography service. In addition, efficacy will be evaluated by the Investigator's mean global assessment of improvement and the subject's mean assessment of improvement. Safety will be evaluated by continuous monitoring of adverse events (AEs) and measuring pain associated with laser treatment.

Conditions

• Telangiectasis
• Spider Veins

Interventions

Type	Name	Description
DEVICE	532 nm KTP Excel V Laser, manufactured by Cutera, Inc.	The 532 nm KTP Excel V laser treatment parameters to be used in this study are as follows: * Spot Size: 5 mm * Fluence: 13-15 J/cm2 * Pulse Duration: 40 ms * Epidermal contact-cooling: 5° Celsius

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2011-05-30
• Last updated: 2015-01-29
• Results posted: 2015-01-29

Locations

1 site across 1 country: United States