The primary objective is to compare physician-assessed clearance of telangiectatic veins between treatment legs using the Physician Global Aesthetic Improvement Scale (PGAIS). Secondary objectives include assessment of procedural pain, safety outcomes, and patient satisfaction.
This is a prospective, double-blind, split-body, randomized, controlled pilot study enrolling twenty (20) adult subjects. Subjects with reticular veins (≥1 mm) will first undergo pre-treatment with foamed sodium tetradecyl sulfate (STS) using the investigator's standard technique. Subjects without reticular veins will proceed directly to telangiectasia treatment. At a subsequent treatment visit approximately four weeks later, subjects will undergo split-leg sclerotherapy for telangiectatic veins (\<1 mm), with one leg randomized to receive glycerin compounded with 1% lidocaine, and the contralateral leg randomized to receive glycerin compounded with 1% lidocaine and epinephrine (1:100,000). Each subject will serve as their own control.Both the treating investigator and the subject will remain blinded to treatment allocation. Efficacy assessments will be performed by a non-treating, blinded investigator.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
20
Right leg treated with glycerin compounded with 1% lidocaine and epinephrine
Left leg treated with glycerin compounded with 1% lidocaine and epinephrine
West Dermatology Research Center
San Diego, California, United States
Physician Global Aesthetic Improvement Scale PGAIS
Please rate right leg veins: Circle One * 2 Much Improved * 1 Improved 0 No Change * 1 Worse * 2 Much Worse Please rate left leg veins: Circle One * 2 Much Improved * 1 Improved 0 No Change * 1 Worse * 2 Much Worse
Time frame: Day 90
Patient Satisfaction Likert Score for vein improvement
Please rate right leg veins: Circle One 1. Strongly Disagree 2. Disagree 3. Neutral 4. Agree 5. Strongly Agree Please rate left leg veins: Circle One 1. Strongly Disagree 2. Disagree 3. Neutral 4. Agree 5. Strongly Agree
Time frame: Day 90
Visual Analog Pain Scale Post Treatment
Please rate pain for right leg: Circle One 0 No Pain 1-3 Mild 4-6 Moderate to Severe 7-9 Very Severe 10 Worst Pain Possible Please rate pain for left leg: Circle One 0 No Pain 1-3 Mild 4-6 Moderate to Severe 7-9 Very Severe 10 Worst Pain Possible
Time frame: Day 1 and Day 30
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