Up to 30 enrolled subjects will be treated. Enrolled subjects will receive Ultherapy® treatments along each length of the spider vein. Follow-up visits will occur at 30 and 60 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
This study is a prospective, single center, clinical trial to be conducted at one clinical site. Enrolled subjects will receive up to three Ultherapy® treatments at a single depth, 14 days apart, using a 10-1.5mm transducer. Treatment will be provided along each length of the spider vein and up to four veins will be treated per subject Maximum length of each vein treated is 2cm.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
SINGLE
Enrollment
9
Micro-focused ultrasound energy delivered below the surface of the skin
Ulthera, Inc.
Mesa, Arizona, United States
Improvement of leg telangiectasia
Determined by a masked, qualitative assessment of 2D photographs compared to baseline, based on level of clearance/improvement. Level of improvement scale: * 0 = 0% Improvement (None) * 1 = \< 25% Improvement (Mild) * 2 = 26 to 50% Improvement (Moderate) * 3 = 51 to 75% Improvement (Significant) * 4 = 76 to 100% Improvement (Very Significant)
Time frame: 60 days post-treatment
Clinician assessment of overall aesthetic improvement
Overall aesthetic improvement will be assessed using the Global Aesthetic Improvement Scale: 1. Very Much Improved: Optimal cosmetic result in this subject. 2. Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal for this subject. 3. Improved: Obvious improvement in appearance from initial condition, but a re-treatment is indicated. 4. No Change: The appearance is essentially the same as the original condition. 5. Worse: The appearance is worse than the original condition.
Time frame: 30 days post-treatment
Clinician assessment of overall aesthetic improvement
Overall aesthetic improvement will be assessed using the Global Aesthetic Improvement Scale: 1. Very Much Improved: Optimal cosmetic result in this subject. 2. Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal for this subject. 3. Improved: Obvious improvement in appearance from initial condition, but a re-treatment is indicated. 4. No Change: The appearance is essentially the same as the original condition. 5. Worse: The appearance is worse than the original condition.
Time frame: 60 days post-treatment
Subject assessment of overall aesthetic improvement
Overall aesthetic improvement will be assessed using the Global Aesthetic Improvement Scale: 1. Very Much Improved: Optimal cosmetic result in this subject. 2. Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal for this subject. 3. Improved: Obvious improvement in appearance from initial condition, but a re-treatment is indicated. 4. No Change: The appearance is essentially the same as the original condition. 5. Worse: The appearance is worse than the original condition.
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Time frame: 30 days post-treatment
Subject assessment of overall aesthetic improvement
Overall aesthetic improvement will be assessed using the Global Aesthetic Improvement Scale: 1. Very Much Improved: Optimal cosmetic result in this subject. 2. Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal for this subject. 3. Improved: Obvious improvement in appearance from initial condition, but a re-treatment is indicated. 4. No Change: The appearance is essentially the same as the original condition. 5. Worse: The appearance is worse than the original condition.
Time frame: 60 days post-treatment
Patient Satisfaction
Subjects will rate their satisfaction with the outcome of their treatment based on completion of a patient satisfaction questionnaire using the following scale: * Very Satisfied * Satisfied * Slightly Satisfied * Neither Satisfied or Dissatisfied * Dissatisfied
Time frame: 30 days post-treatment
Patient Satisfaction
Subjects will rate their satisfaction with the outcome of their treatment based on completion of a patient satisfaction questionnaire using the following scale: * Very Satisfied * Satisfied * Slightly Satisfied * Neither Satisfied or Dissatisfied * Dissatisfied
Time frame: 60 days post-treatment