A Single-center Prospective Double-Blind, Split-Body, Randomized Clinical Study Comparing Glycerin With 1% Lidocaine and Epinephrine Versus Glycerin With 1% Lidocaine Without Epinephrine for the Sclerotherapy of Leg Telangiectasias
Goldman, Butterwick, Fitzpatrick and Groff
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.
Description
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 contra…
Eligibility
- Age range
- 20–75 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Subjects aged 20-75years. 2. Fitzpatrick skin types I-VI. 3. Presence of lower extremity telangiectatic veins (\<1 mm) suitable for sclerotherapy (reticular veins ≥1 mm can be present but are not required). 4. Duplex ultrasonography negative for saphenous vein reflux in both legs. 5. Willing to undergo split-leg randomization (CG + 1% lidocaine vs CG + 1% lidocaine with epinephrine 1:100,000). 6. 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 asses…
Interventions
- DrugRight leg treated with Glycerin compounded with 1% Lidocaine and Epinephrine
Right leg treated with glycerin compounded with 1% lidocaine and epinephrine
- DrugLeft leg treated with Glycerin compounded with 1% Lidocaine and Epinephrine
Left leg treated with glycerin compounded with 1% lidocaine and epinephrine
Location
- West Dermatology Research CenterSan Diego, California