Clinical trial NCT01362192: Treatment of Lower Extremity Spider Veins With Excel V
Official title: A Clinical Evaluation of the Treatment of Lower Extremity Spider Veins Using a Dual Wavelength Laser Emitting 532 nm and 1064 nm Laser Energy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Telangiectasis
Spider Veins
Keywords: Telangiectasis
Spider Veins
Excel V
Cutera
Laser
Leg Veins
Venulectasia
Lower Extremity veins
Laser light
KTP
532nm
Lead sponsor: Cutera Inc.
Sponsor class: INDUSTRY
First posted: 2011-05-30
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean Improvement of Lower Extremity Spider Veins Based on Blinded Photo Assessments
timeFrame: 24 weeks (12 weeks post-final laser treatment)
Secondary outcomes:
measure: Mean Improvement of Lower Extremity Spider Veins Based on Blinded Photo Assessments
timeFrame: 12 weeks (post-1st laser treatment)
measure: Percent of Subjects With "Significant" or "Very Significant" Improvement in Lower Extremity Spider Veins, as Assessed by the Treating Investigator.
timeFrame: 24 weeks (12 weeks post-final laser treatment)
measure: Percent of Subjects With "Significant" to "Very Significant" Improvement of Lower Extremity Spider Veins, as Assessed by Subject.
timeFrame: 24 weeks (12 weeks post-final laser treatment)
measure: Percent of Subjects Satisfied With Improvement of Treated Spider Veins.
timeFrame: 24 weeks (12 weeks post-final laser treatment)
measure: Mean Pain Score Associated With Laser Treatment.
timeFrame: Day 0 (1st laser treatment)
measure: Mean Pain Score Associated With Laser Treatment
timeFrame: 12 weeks (2nd laser treatment)
Other outcomes:
Locations:
city: Ardmore
country: United States
facility: Main Line Center for Laser Surgery
state: Pennsylvania
Study officials:
References: