NCT07342413

Study Comparing Glycerin With 1% Lidocaine and Epinephrine Versus Glycerin With 1% Lidocaine Without Epinephrine for the Sclerotherapy of Leg Telangiectasias

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Goldman, Butterwick, Fitzpatrick and Groff · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed 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 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.

Conditions

• Leg Veins

Interventions

Type	Name	Description
DRUG	Right leg treated with Glycerin compounded with 1% Lidocaine and Epinephrine	Right leg treated with glycerin compounded with 1% lidocaine and epinephrine
DRUG	Left leg treated with Glycerin compounded with 1% Lidocaine and Epinephrine	Left leg treated with glycerin compounded with 1% lidocaine and epinephrine

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-05-30
• Completion: 2026-07-30
• First posted: 2026-01-15
• Last updated: 2026-01-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study