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 range20 Years – 75 Years
SexALL
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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.
✓. 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
. 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