Treatment of Lower Extremity Spider Veins With Excel V
Condition: Telangiectasis; Spider Veins
MeSH terms: Telangiectasis
Intervention: 532 nm KTP Excel V Laser, manufactured by Cutera, Inc.
Intervention description: 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
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 21 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Telangiectasis; Spider Veins; Excel V; Cutera; Laser; Leg Veins; Venulectasia; Lower Extremity veins; Laser light; KTP; 532nm

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.
    

Eligibility criteria:

        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