Treatment of Lower Extremity Spider Veins With Excel V

Phase 4

Completed

Conditions: Telangiectasis
Spider Veins

Interventions: Device: 532 nm KTP Excel V Laser, manufactured by Cutera, Inc.

Registration Number: NCT01362192

Lead Sponsor: Cutera Inc.

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

Inclusion Criteria

Fitzpatrick Skin Type I - III
Having at least 2 separate areas measuring 5cm x 5cm of lower extremity spider veins
Having lower extremity spider veins less than 2.0mm in diameter, linear or branching, and red, pink, blue and/or purple in color, as assessed by the Investigator
Having lower extremity spider veins appropriate for laser treatment, as assessed by the Investigator
Subject must be able to read, understand and sign the Informed Consent Form
Subject must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions
Wiling to have limited sun exposure for the duration of the study, including the follow-up period
Willingness to have digital photographs taken of lower extremity spider veins
Agree not to undergo any other procedure for the treatment of lower extremity spider veins during the study
Willing to not take any 'prn' medications for aches and pains (such as Tylenol® or Advil®) on the days of the laser treatments
For female candidates - post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study

Exclusion Criteria

Having received any prior laser treatment for lower extremity spider veins
Fitzpatrick Skin Type IV - VI
Pregnant
Having an infection, dermatitis or a rash in the treatment area
Having significant varicosities or perforator veins
History of keloid scarring, hypertrophic scarring or of abnormal wound healing
History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications
History of connective tissue disease, such as systemic lupus erythematosus or scleroderma
History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation
Having a known anticoagulative condition or taking anticoagulation medications
History of thromboembolic disease, such as deep vein thrombosis (DVT)
History of seizure disorders due to light
Having a history of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area, unless treatment is conducted following a prophylactic regimen
Having undergone any surgery in the treatment area within 6 months of treatment (or more if skin has not healed completely)
Suffering from significant concurrent illness, such as insulin-dependent diabetes (type I or II), peripheral vascular disease or peripheral neuropathy
Undergoing systemic chemotherapy for the treatment of cancer
Systemic use of isotretinoin (Accutane®) within 6 months of study participation
Any use of gold therapy for disorders such as rheumatologic disease or lupus
Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study
Participation in a study of another device or drug within three months prior to enrollment or during the study
As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
532 nm KTP Laser Treatment	532 nm KTP Excel V Laser, manufactured by Cutera, Inc.	-

Primary Outcome Measures

Name	Time	Method
Mean Improvement of Lower Extremity Spider Veins Based on Blinded Photo Assessments	24 weeks (12 weeks post-final laser treatment)	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%)

Secondary Outcome Measures

Name	Time	Method
Mean Improvement of Lower Extremity Spider Veins Based on Blinded Photo Assessments	12 weeks (post-1st laser treatment)	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%)
Percent of Subjects With "Significant" or "Very Significant" Improvement in Lower Extremity Spider Veins, as Assessed by the Treating Investigator.	24 weeks (12 weeks post-final laser treatment)	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%)
Percent of Subjects With "Significant" to "Very Significant" Improvement of Lower Extremity Spider Veins, as Assessed by Subject.	24 weeks (12 weeks post-final laser treatment)	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%)
Percent of Subjects Satisfied With Improvement of Treated Spider Veins.	24 weeks (12 weeks post-final laser treatment)	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
Mean Pain Score Associated With Laser Treatment.	Day 0 (1st 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).
Mean Pain Score Associated With Laser Treatment	12 weeks (2nd 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).