Treatment of Lower Extremity Spider Veins With Excel V

NCT ID: NCT01362192

Last Updated: 2015-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2011-11-30

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.

Conditions

Telangiectasis; Spider Veins

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

532 nm KTP Laser Treatment

Group Type: OTHER

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

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

Excel V laser; ExcelV; KTP; 532nm

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cutera Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Main Line Center for Laser Surgery

Ardmore, Pennsylvania, United States

Countries

United States

Other Identifiers

C-11-XLV01

Identifier Type: -

Identifier Source: org_study_id