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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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
Main Line Center for Laser Surgery
Ardmore, Pennsylvania, United States
Mean Improvement of Lower Extremity Spider Veins Based on Blinded Photo Assessments
A panel of independent physicians will assess before and after digital photographs of each treated area. The physicians will be blinded to the treatment parameters and to the temporal order of the before and after photographs. Each independent physician will be asked to select the baseline photograph for each treated area and then rate the degree of improvement using the following scale: * 0 = No Improvement (0%) * 1 = Mild Improvement (\< 25%) * 2 = Moderate Improvement (26 to 50%) * 3 = Significant Improvement (51 to 75%) * 4 = Very Significant Improvement (76 to 100%)
Time frame: 24 weeks (12 weeks post-final laser treatment)
Mean Improvement of Lower Extremity Spider Veins Based on Blinded Photo Assessments
The panel of independent physicians will be asked to select the baseline photograph for each treated area and then rate the degree of improvement using the following scale: * 0 = No Improvement (0%) * 1 = Mild Improvement (\< 25%) * 2 = Moderate Improvement (26 to 50%) * 3 = Significant Improvement (51 to 75%) * 4 = Very Significant Improvement (76 to 100%)
Time frame: 12 weeks (post-1st laser treatment)
Percent of Subjects With "Significant" or "Very Significant" Improvement in Lower Extremity Spider Veins, as Assessed by the Treating Investigator.
The Investigator will perform the Physician's Global Assessment of the degree of improvement for each treated area of the subject's lower extremity spider veins using the following scale: * 0 = No Improvement (0%) * 1 = Mild Improvement (\< 25%) * 2 = Moderate Improvement (26 to 50%) * 3 = Significant Improvement (51 to 75%) * 4 = Very Significant Improvement (76 to 100%)
Time frame: 24 weeks (12 weeks post-final laser treatment)
Percent of Subjects With "Significant" to "Very Significant" Improvement of Lower Extremity Spider Veins, as Assessed by Subject.
Subjects will be asked to rate the improvement of each treated area of their lower extremity spider veins as compared to baseline using the following scale: * 0 = No Improvement (0%) * 1 = Mild Improvement (\< 25%) * 2 = Moderate Improvement (26 to 50%) * 3 = Significant Improvement (51 to 75%) * 4 = Very Significant Improvement (76 to 100%)
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Time frame: 24 weeks (12 weeks post-final laser treatment)
Percent of Subjects Satisfied With Improvement of Treated Spider Veins.
Subjects will assess their satisfaction with the procedure and with the improvement in lower extremity spider veins at twelve weeks post final laser treatment based using the following scale: * 1 = Very Much Not Satisfied * 2 = Not Satisfied * 3 = Somewhat Satisfied * 4 = Satisfied * 5 = Very Much Satisfied
Time frame: 24 weeks (12 weeks post-final laser treatment)
Mean Pain Score Associated With Laser Treatment.
Subjects will be asked to rate the average pain experienced during laser treatments using the 0-10 numeric pain rating scale (0 = no pain to 10 = worst possible pain).
Time frame: Day 0 (1st laser treatment)
Mean Pain Score Associated With Laser Treatment
Subjects will be asked to rate the average pain experienced during laser treatments using the 0-10 numeric pain rating scale (0 = no pain to 10 = worst possible pain).
Time frame: 12 weeks (2nd laser treatment)