Leg VeinsPhase 4NCT07342413
Study Comparing Glycerin With 1% Lidocaine and Epinephrine Versus Glycerin With 1% Lidocaine Without Epinephrine for the Sclerotherapy of Leg Telangiectasias
A Phase 4 study testing Right leg treated with Glycerin compounded with 1% Lidocaine and Epinephrine and Left leg treated with Glycerin compounded with 1% Lidocaine and Epinephrine in people with Leg Veins, run by Goldman, Butterwick, Fitzpatrick and Groff at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Leg Veins
- What is being tested?
- Right leg treated with Glycerin compounded with 1% Lidocaine and Epinephrine and Left leg treated with Glycerin compounded with 1% Lidocaine and Epinephrine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2026to 30 Jul 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects aged 20-75years.
- Fitzpatrick skin types I-VI.
- Presence of lower extremity telangiectatic veins (<1 mm) suitable for sclerotherapy (reticular veins ≥1 mm can be present but are not required).
- Duplex ultrasonography negative for saphenous vein reflux in both legs.
- Willing to undergo split-leg randomization (CG + 1% lidocaine vs CG + 1% lidocaine with epinephrine 1:100,000).
- 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.
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- Subject with no known history of coagulopathy/platelet disorders (eg., hemophilia, von Willebrand disease) or liver disease/cirrhosis
- 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 malignancy
- Subjects in good general health as determined by the investigator's judgment and medical history.
- Participants must be willing to provide written informed consent and sign a photography release for research and potential publication. Subjects must also agree to complete all study visits and procedures.
- 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.
- Negative urine pregnancy test result at the time of study entry and all subsequent visits (if applicable)
- Subjects of childbearing potential must agree to use an effective method of birth control 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.
- 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.
- A female is considered of non-childbearing potential if she is: postmenopausal (no menses for at least 12 months/≥ 12 months of amenorrhea without another medical cause), without a uterus (hysterectomy) and/or both ovaries (oophorectomy).
Who cannot join
- Positive duplex ultrasonography demonstrating saphenous vein reflux.
- Prior sclerotherapy or vascular laser treatment to the lower extremities within the past 6 months prior to screening/baseline
- History of ulceration, thrombophlebitis, or deep vein thrombosis (DVT) in the lower extremities.
- Active infection, open wounds, or inflammatory dermatoses (e.g., eczema, psoriasis, dermatitis) in the treatment area.
- Known allergy or hypersensitivity to lidocaine, epinephrine, or glycerin.
- Any uncontrolled systemic condition that may increase risk or interfere with study participation (e.g., poorly managed diabetes, thyroid dysfunction, cardiovascular disease).
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- Pregnancy, intent to become pregnant during the study period, or current breastfeeding.
- Clinically significant psychiatric or psychological conditions that, in the opinion of the investigator, may interfere with compliance or interpretation of results
- Participation in another clinical study within 30 days prior to enrollment of this study or during this study.
- 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.
- Unwillingness to follow a wash-out period of 4 weeks prior to screening for self-tanner application.
- Unwillingness to refrain from self-tanner application for 1 month prior to any visits.
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
West Dermatology Research Center
San Diego, California, 92121
About this study
Official title: 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
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.
- Conditions
- Leg Veins
- Being tested
- Right leg treated with Glycerin compounded with 1% Lidocaine and Epinephrine, Left leg treated with Glycerin compounded with 1% Lidocaine and Epinephrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right leg treated with Glycerin compounded with 1% Lidocaine and EpinephrineDrug
Right leg treated with glycerin compounded with 1% lidocaine and epinephrine
Left leg treated with Glycerin compounded with 1% Lidocaine and EpinephrineDrug
Left leg treated with glycerin compounded with 1% lidocaine and epinephrine
| Study group | Role | What they receive |
|---|---|---|
| Group A Right Leg Treated with glycerin compounded 1% lidocaine and epinephrine | Active comparator | 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. Receives: Drug: Right leg treated with Glycerin compounded with 1% Lidocaine and Epinephrine |
| Group B Left Leg Treated with glycerin compounded 1% lidocaine and epinephrine | Sham comparator | 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. Receives: Drug: Left leg treated with Glycerin compounded with 1% Lidocaine and Epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 90
Secondary outcomes (2)
Patient Satisfaction Likert Score for vein improvement
Please rate right leg veins:
Circle One
- Strongly Disagree
- Disagree
- Neutral
- Agree
- Strongly Agree
Please rate left leg veins:
Circle One
- Strongly Disagree
- Disagree
- Neutral
- Agree
- Strongly Agree
Measured: Day 90
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
Measured: Day 1 and Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leg VeinsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and Groff
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07342413
- Sponsor's protocol ID
- Sclero-Epi-2025
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07342413
- Acronym / sponsor ID
- Sclero-Epi-2025
- Conditions
- Leg Veins
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and GroffUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A Right Leg Treated with glycerin compounded 1% lidocaine and epinephrine | Active comparator | Drug: Right leg treated with Glycerin compounded with 1% Lidocaine and EpinephrineSubjects 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 B Left Leg Treated with glycerin compounded 1% lidocaine and epinephrine | Sham comparator | Drug: Left leg treated with Glycerin compounded with 1% Lidocaine and EpinephrineSubjects 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 may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subjects aged 20-75years.
- Fitzpatrick skin types I-VI.
- Presence of lower extremity telangiectatic veins (<1 mm) suitable for sclerotherapy (reticular veins ≥1 mm can be present but are not required).
- Duplex ultrasonography negative for saphenous vein reflux in both legs.
- Willing to undergo split-leg randomization (CG + 1% lidocaine vs CG + 1% lidocaine with epinephrine 1:100,000).
Key exclusion criteria (13 listed)
- Positive duplex ultrasonography demonstrating saphenous vein reflux.
- Prior sclerotherapy or vascular laser treatment to the lower extremities within the past 6 months prior to screening/baseline
- History of ulceration, thrombophlebitis, or deep vein thrombosis (DVT) in the lower extremities.
- Active infection, open wounds, or inflammatory dermatoses (e.g., eczema, psoriasis, dermatitis) in the treatment area.
- Known allergy or hypersensitivity to lidocaine, epinephrine, or glycerin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Right leg treated with Glycerin compounded with 1% Lidocaine and EpinephrineRight leg treated with glycerin compounded with 1% lidocaine and epinephrine | Drug | Group A Right Leg Treated with glycerin compounded 1% lidocaine and epinephrine |
| Left leg treated with Glycerin compounded with 1% Lidocaine and EpinephrineLeft leg treated with glycerin compounded with 1% lidocaine and epinephrine | Drug | Group B Left Leg Treated with glycerin compounded 1% lidocaine and epinephrine |
Primary outcome
Physician Global Aesthetic Improvement Scale PGAIS
Time frame: Day 90
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
2 secondary outcomes
Patient Satisfaction Likert Score for vein improvement
Time frame: Day 90
Visual Analog Pain Scale Post Treatment
Time frame: Day 1 and Day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Right leg treated with Glycerin compounded with 1% Lidocaine and Epinephrine and Left leg treated with Glycerin compounded with 1% Lidocaine and Epinephrine in people with Leg Veins, run by Goldman, Butterwick, Fitzpatrick and Groff at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Pacheco (858-657-1004, apacheco@clderm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician Global Aesthetic Improvement Scale PGAIS (time frame: Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.