ClinicalTrials.gg
Not yet recruitingNCT07342413Updated Jan 15, 2026

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

A Phase 4 interventional study of Right leg treated with Glycerin compounded with 1% Lidocaine and Epinephrine and Left leg treated with Glycerin compounded with 1% Lidocaine and Epinephrine in Leg Veins, sponsored by Goldman, Butterwick, Fitzpatrick and Groff. Not yet recruiting at 1 site in United States. Open to participants aged 20 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-15.

Sponsored by Goldman, Butterwick, Fitzpatrick and Groff · Phase 4, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by May 2026, 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 4
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Leg Veins
03

In context

Lead sponsor

Goldman, Butterwick, Fitzpatrick and Groff is the lead sponsor of 41 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 assessments, and post-treatment compression therapy consisting of graduated 30-40 mmHg stockings worn 24 hours/day for 1 week following treatment.
  7. Subject with no known history of coagulopathy/ disorders (eg., hemophilia, von Willebrand disease) or liver disease/cirrhosis
  8. 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
  9. Subjects in good general health as determined by the investigator's judgment and medical history.
  10. Participants must be willing to provide written and sign a photography release for research and potential publication. Subjects must also agree to complete all study visits and procedures.
  11. Willing to avoid new lower-extremity aesthetic/vascular treatments (e.g., sclerotherapy, vascular lasers) and agree to avoid self-tanners or spray tans on the legs during the study period.
  12. Negative urine pregnancy test result at the time of study entry and all subsequent visits (if applicable)
  13. Subjects of must agree to use an effective method of during the entire course of the study. All systemic birth control measures must be in consistent use for at least 30 days prior to study enrollment.

    1. Acceptable forms of birth control are: oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device/coil, bilateral tubal ligation, double-barrier methods (e.g., sponge, spermicide, or condoms). Abstinence and/or vasectomized partner must agree to a second acceptable method of birth control (double-barrier) should the subject become sexually active.
    2. A female is considered of non-childbearing potential if she is: (no menses for at least 12 months/≥ 12 months of amenorrhea without another medical cause), without a uterus (hysterectomy) and/or both ovaries (oophorectomy).

Exclusion criteria

Exclusion Criteria:

  1. Positive duplex ultrasonography demonstrating saphenous vein reflux.
  2. Prior sclerotherapy or vascular laser treatment to the lower extremities within the past 6 months prior to screening/baseline
  3. History of ulceration, thrombophlebitis, or deep vein thrombosis (DVT) in the lower extremities.
  4. Active infection, open wounds, or inflammatory dermatoses (e.g., eczema, psoriasis, dermatitis) in the treatment area.
  5. Known allergy or to lidocaine, epinephrine, or glycerin.
  6. Any uncontrolled systemic condition that may increase risk or interfere with study participation (e.g., poorly managed diabetes, thyroid dysfunction, cardiovascular disease).
  7. Pregnancy, intent to become pregnant during the study period, or current breastfeeding.
  8. psychiatric or psychological conditions that, in the opinion of the investigator, may interfere with compliance or interpretation of results
  9. Participation in another clinical study within 30 days prior to enrollment of this study or during this study.
  10. Unwillingness to refrain from additional lower extremity aesthetic/vascular treatments (e.g., sclerotherapy, vascular lasers, self-tanning) from the screening/baseline visit through the end of study.
  11. Unwillingness to follow a of 4 weeks prior to screening for self-tanner application.
  12. Unwillingness to refrain from self-tanner application for 1 month prior to any visits.
  13. Unwillingness or inability to comply with post-treatment compression therapy consisting of graduated 30-40 mmHg stockings worn 24 hours/day for 1 week following treatment
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    Group A Right Leg Treated with glycerin compounded 1% lidocaine and epinephrine

    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.

    Drug: Right leg treated with Glycerin compounded with 1% Lidocaine and Epinephrine

  • Sham comparator
    Group B Left Leg Treated with glycerin compounded 1% lidocaine and epinephrine

    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.

    Drug: Left leg treated with Glycerin compounded with 1% Lidocaine and Epinephrine

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

06

What researchers measure

Primary outcomes

  1. Physician Global Aesthetic Improvement Scale PGAIS

    Please rate right leg veins: Circle One * 2 Much Improved * 1 Improved 0 No Change * 1 Worse * 2 Much Worse Please rate left leg veins: Circle One * 2 Much Improved * 1 Improved 0 No Change * 1 Worse * 2 Much Worse

    Time frame: Day 90

Secondary outcomes

  1. Patient Satisfaction Likert Score for vein improvement

    Please rate right leg veins: Circle One 1. Strongly Disagree 2. Disagree 3. Neutral 4. Agree 5. Strongly Agree Please rate left leg veins: Circle One 1. Strongly Disagree 2. Disagree 3. Neutral 4. Agree 5. Strongly Agree

    Time frame: Day 90

  2. Visual Analog Pain Scale Post Treatment

    Please rate pain for right leg: Circle One 0 No Pain 1-3 Mild 4-6 Moderate to Severe 7-9 Very Severe 10 Worst Pain Possible Please rate pain for left leg: Circle One 0 No Pain 1-3 Mild 4-6 Moderate to Severe 7-9 Very Severe 10 Worst Pain Possible

    Time frame: Day 1 and Day 30

07

Study locations

1 site
  • West Dermatology Research Center
    San Diego, California 92121, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Feb 2026; primary completion for May 2026, 3 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 13, 2026
First posted
Jan 15, 2026
StartEst.
Feb 1, 2026
Primary completionEst.
May 30, 2026
CompletionEst.
Jul 30, 2026
Last update
Jan 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07342413
Lead sponsor
Goldman, Butterwick, Fitzpatrick and Groff
Responsible party
Sponsor
First posted
Jan 15, 2026
Start date
Feb 1, 2026 (estimated)
Primary completion
May 30, 2026 (estimated)
Completion
Jul 30, 2026 (estimated)
Last update
Jan 15, 2026

Study contacts

Andrea Pacheco
Contact
apacheco@clderm.com
858-657-1004

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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