Clinical Evaluation of the Treatment of Spider Angioma

Study Overview
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Brief Summary
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To evaluate the safety and effectiveness of the laser treatment for the treatment of spider angiomas.

Detailed Description
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The purpose of this study is to evaluate the safety and efficacy of the 532 nm KTP laser within the Cutera Excel V system for the treatment of spider angiomas.

Official Title
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A Clinical Evaluation of the Treatment of Spider Angioma Using a Dual Wavelength Laser Emitting 532 nm Laser Energy

Conditions
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Spider Angioma

Intervention / Treatment
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* Device: KTP laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females, 5 to 65 years of age (inclusive). Fitzpatrick Skin Types I-IV Subject must be able to read, understand and sign the Informed Consent Form. If subject is a minor (<18 years old in Illinois), Assent must be obtained from the subject and a Parental Consent Form must be signed by the parents or legal guardian. Subject must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions. Willing to have limited sun exposure for the duration of the study, including the follow-up period. Willingness to have digital photographs taken of their spider angioma(s) and agree to use of photographs for presentation, educational or marketing purposes Agree not to undergo any other procedure for the treatment of spider angioma during the study. Exclusion Criteria: Pregnant. History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation. Having a known anti-coagulative condition or taking anticoagulation medications, including aspirin. History of seizure disorders due to light. 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. Participation in a study of another device or drug within 3 months prior to enrollment or 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: 5 Years
Maximum Age: 65 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 treatment<br>Each subject will receive a 532 nm KTP laser treatment for their spider angioma(s). | Device: KTP laser<br>* Dual Wavelength Laser Emitting 532 nm Laser Energy<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's Global Assessment Scale for Improvement of Spider Angioma | Assessment of Baseline vs. 4 weeks post-final treatment for improvement of spider angiomas using the Physician's Global Assessment scale. High scores indicate better outcomes: 0. None Mild Moderate Significant Very Significant Complete Removal | Four weeks post laser treatment. |