A Clinical Evaluation of the Treatment of Spider Veins on the Ankles

Study Overview
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Brief Summary
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To evaluate the safety and effectiveness of the Excel V system for the treatment of lower extremity spider veins on the ankles.

Detailed Description
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The purpose of this study is to evaluate the real-world effectiveness of the 532 nm and 1064 nm Nd:YAG lasers within the Cutera Excel V system for the treatment of lower extremity spider veins, specifically on the ankles, within a clinic setting.

Official Title
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A Clinical Evaluation of the Treatment of Spider Veins on the Ankles Using a Dual Wavelength Laser Emitting 532 nm and 1064 nm Laser Energy

Conditions
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Spider Veins

Intervention / Treatment
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* Device: Nd:YAG laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females, 20 to 75 years of age (inclusive). Fitzpatrick Skin Type I - III. Having spider veins on at least 1 ankle measuring 2.0mm or less in diameter, linear or branching, and red, pink, blue and/or purple in color, as assessed by the investigator. Having spider veins on the ankle that are 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 ankle spider veins and agree to use of photographs for presentation, educational or marketing purposes. Agree not to undergo any other procedure for the treatment of ankle spider veins during the study. Exclusion Criteria: 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 pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation. Systemic use of isotretinoin (Accutane®) within 6 months of study participation. Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study. In the opinion of the investigator, any physical or mental condition which might make it unsafe for the subject to participate in this study or which requires systemic therapy that could interfere with this research study.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser treatments<br>Each subject will receive a combination of 532 nm and/or 1064 nm Nd:YAG laser treatment | Device: Nd:YAG laser<br>* Treatment of lower extremity spider veins<br>* Other names: Cutera Excel V;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician Global Assessment of Improvement in Treated Spider Veins on the Ankles | Improvement in treated ankle spider veins at 4 weeks post final laser treatment (compared to baseline) as assessed by a blinded evaluators Physician Global Assessment Scale score (Min=0; 4= Max). Higher Score Indicates Better Outcome. | Four weeks post final laser treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Satisfaction With Improvement in Treated Spider Veins on the Ankles | Subject satisfaction with improvement in spider veins on the ankles as assessed using the Subject Satisfaction Assessment scale (Min=1, Max=5) at 4 weeks post final treatment. Higher score indicates better outcome. | Four weeks post final laser treatment |