Treatment of Lower Extremity Spider Veins With Excel V

Completed · Phase 4

Conditions studied: Telangiectasis, Spider Veins

In brief

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.

Key facts

Study ID

NCT01362192

Run by

Cutera Inc.

People needed

20

Starts

2011-05-01

Expected to finish

2011-11-01

Last updated by the study team

2015-01-29

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Main Line Center for Laser Surgery — Ardmore, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.