Study Comparing Glycerin With 1% Lidocaine and Epinephrine Versus Glycerin With 1% Lidocaine With… (NCT07342413) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Study Comparing Glycerin With 1% Lidocaine and Epinephrine Versus Glycerin With 1% Lidocaine Without Epinephrine for the Sclerotherapy of Leg Telangiectasias
United States20 participantsStarted 2026-02-01
Plain-language summary
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.
Who can participate
Age range
20 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects aged 20-75years.
. Fitzpatrick skin types I-VI.
. Presence of lower extremity telangiectatic veins (\<1 mm) suitable for sclerotherapy (reticular veins ≥1 mm can be present but are not required).
. Duplex ultrasonography negative for saphenous vein reflux in both legs.
. Willing to undergo split-leg randomization (CG + 1% lidocaine vs CG + 1% lidocaine with epinephrine 1:100,000).
. Willing and able to comply with all study procedures, including standardized photography, in-person evaluations by a non-treating physician investigator, Day 90 follow-up assessments, and post-treatment compression therapy consisting of graduated 30-40 mmHg stockings worn 24 hours/day for 1 week following treatment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Physician Global Aesthetic Improvement Scale PGAIS
. Subject with no known history of coagulopathy/platelet disorders (eg., hemophilia, von Willebrand disease) or liver disease/cirrhosis
. Subject with no history of hypercoagulable disorder such as pulmonary embolism, deep vein thrombosis, factor V Leiden mutation, Protein C or S deficiency, antiphospholipid syndrome, or active malignancy
. Prior sclerotherapy or vascular laser treatment to the lower extremities within the past 6 months prior to screening/baseline
. History of ulceration, thrombophlebitis, or deep vein thrombosis (DVT) in the lower extremities.
. Active infection, open wounds, or inflammatory dermatoses (e.g., eczema, psoriasis, dermatitis) in the treatment area.
. Known allergy or hypersensitivity to lidocaine, epinephrine, or glycerin.
. Any uncontrolled systemic condition that may increase risk or interfere with study participation (e.g., poorly managed diabetes, thyroid dysfunction, cardiovascular disease).
. Pregnancy, intent to become pregnant during the study period, or current breastfeeding.
. Clinically significant psychiatric or psychological conditions that, in the opinion of the investigator, may interfere with compliance or interpretation of results