Glycerin + Lidocaine Formulations for Varicose Veins

Overseen By Andrea Pacheco

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Goldman, Butterwick, Fitzpatrick and Groff

Disqualifiers: Saphenous vein reflux, DVT, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for individuals aged 20-75 with varicose veins suitable for sclerotherapy, without a history of blood clotting disorders or liver disease. They must be in good health, have no saphenous vein reflux, and agree to random treatment on each leg, follow-up assessments, and wear compression stockings after treatment.

Inclusion Criteria

I am between 20 and 75 years old.

My skin type is within the range of very light to very dark.

I have small visible veins on my legs that can be treated with injections.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment

Subjects with reticular veins undergo pre-treatment with foamed sodium tetradecyl sulfate (STS)

4 weeks

1 visit (in-person)

Treatment

Subjects undergo split-leg sclerotherapy for telangiectatic veins with randomized treatments

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Glycerin with 1% Lidocaine and Epinephrine

Trial Overview

The study compares the effectiveness of glycerin with lidocaine plus epinephrine versus glycerin with just lidocaine in treating leg telangiectasias. It measures vein clearance using PGAIS scale, procedural pain levels, safety outcomes, and patient satisfaction.

How Is the Trial Designed?

Group I: Group A Right Leg Treated with glycerin compounded 1% lidocaine and epinephrine Active Control 1 Intervention

Subjects will be treated with foamed sodium tetradecyl sulfate (STS) to both legs. Four weeks later subjects left leg will be treated with glycerin compounded with 1% lidocaine, and right leg will be treated with glycerin compounded with 1% lidocaine and epinephrine.

Group II: Group B Left Leg Treated with glycerin compounded 1% lidocaine and epinephrine Placebo Group 1 Intervention

Subjects will be treated with foamed sodium tetradecyl sulfate (STS) to both legs. Four weeks later subjects right leg will be treated with glycerin compounded with 1% lidocaine, and left leg will be treated with glycerin compounded with 1% lidocaine and epinephrine.

Who Is Running the Clinical Trial?

Goldman, Butterwick, Fitzpatrick and Groff

Lead Sponsor

Trials

32

Recruited

660+