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?

This trial examines a new treatment for varicose veins, the small veins that appear on the legs. Researchers aim to evaluate the effectiveness of a mixture of glycerin, lidocaine (a numbing agent), and epinephrine (which reduces swelling) compared to other treatments. They will also assess the treatment's comfort, safety, and patient satisfaction. This trial may suit individuals with visible small leg veins who have not recently undergone leg vein treatments. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and the research seeks to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for glycerin with 1% lidocaine and epinephrine?

Research has shown that adding 1% lidocaine and epinephrine to glycerin is generally safe for treating varicose veins. Studies have found that this combination reduces pain during treatment without compromising effectiveness. Safety checks conducted immediately after treatment, and again after one week and two months, revealed no serious issues such as deep vein problems. This indicates that the treatment is well-tolerated. As this is a Phase 4 trial, the treatment has already received approval for other uses, enhancing its safety profile. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for varicose veins typically involve procedures like laser therapy or sclerotherapy using agents such as sodium tetradecyl sulfate (STS), which work by irritating the vein walls to close them off. However, the treatment involving glycerin with 1% lidocaine and epinephrine is unique because it combines a local anesthetic with a vasoconstrictor, potentially enhancing comfort and reducing side effects like bruising and swelling. Researchers are excited about this combination because it could make the procedure more tolerable and effective, offering a potentially quicker recovery and better cosmetic results compared to traditional treatments.

What evidence suggests that this treatment might be an effective treatment for varicose veins?

This trial will evaluate the effectiveness of glycerin compounded with 1% lidocaine and epinephrine for treating varicose veins. Research has shown that adding a small amount of lidocaine and epinephrine to glycerin can significantly reduce pain during sclerotherapy, a treatment for varicose veins, without affecting its efficacy. This combination also effectively clears spider veins. Lidocaine numbs the area, while epinephrine reduces bleeding, making the procedure more comfortable. Studies indicate that this mix improves patient satisfaction by reducing discomfort during treatment. Evidence supports its effectiveness and safety for treating varicose veins, maintaining desired results while enhancing the patient experience. Participants in this trial will receive treatment to both legs, with one leg receiving glycerin compounded with 1% lidocaine and epinephrine, and the other leg receiving a different formulation for comparison. ^{1 2 3 4 6}

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+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/21883648/

A double-blind, randomized study comparing pure ...

Addition of lidocaine-epinephrine 1% to CG, in a ratio of one-third, significantly reduces sclerotherapy pain without affecting efficacy when treating ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07342413

Study Comparing Glycerin With 1% Lidocaine and ...

This is a prospective, double-blind, split-body, randomized, controlled pilot study enrolling twenty (20) adult subjects.

3.

researchgate.net

researchgate.net/publication/51611980_A_Double-Blind_Randomized_Study_Comparing_Pure_Chromated_Glycerin_with_Chromated_Glycerin_with_1_Lidocaine_and_Epinephrine_for_Sclerotherapy_of_Telangiectasias_and_Reticular_Veins

A Double-Blind, Randomized Study Comparing Pure ...

07). Addition of lidocaine-epinephrine 1% to CG, in a ratio of one-third, significantly reduces sclerotherapy pain without affecting efficacy when treating ...

4.

withpower.com

withpower.com/trial/phase-4-leg-veins-1-2026-f5f61

Glycerin + Lidocaine Formulations for Varicose Veins

The study compares the effectiveness of glycerin with lidocaine plus epinephrine versus glycerin with just lidocaine in treating leg ...

5.

ejves.com

ejves.com/article/S1078-5884(20)30615-8/fulltext

Triple Blind, Randomised Controlled Trial (PG3T)

The aim of this study was to compare the effectiveness and safety of two sclerosing agents used to treat telangiectasias in the lower limbs: 0.2 ...

6.

jamanetwork.com

jamanetwork.com/journals/jamadermatology/fullarticle/2653792

Sclerotherapy for Reticular Veins in the Lower Limbs

Safety outcomes were analyzed immediately after treatment and 7 days and 60 days after treatment and included serious adverse events (eg, deep ...