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
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Primary Completion
May 30, 2026
Estimated (date passed)
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Study Completion
July 30, 2026
Estimated (date passed)
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Brief 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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Recruitment status
not yet recruiting
Estimated enrollment
20 participants
Study completion date
July 30, 2026
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations
1 countries · 1 sites
Trial Relationships
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Related Scientific Literature
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
January 13, 2026
Actual (reported)
First Posted
January 15, 2026
Actual (reported)
Study Start
February 1, 2026
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 30, 2026
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 30, 2026
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Day 90
Secondary Outcomes (2)
Patient Satisfaction Likert Score for vein improvement
Day 90
Visual Analog Pain Scale Post Treatment
Day 1 and Day 30
Study Arms (2)
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.
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.
Drug: Left leg treated with Glycerin compounded with 1% Lidocaine and Epinephrine
Interventions
Right leg treated with Glycerin compounded with 1% Lidocaine and EpinephrineDrug
Right leg treated with glycerin compounded with 1% lidocaine and epinephrine
Group A Right Leg Treated with glycerin compounded 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
Group B Left Leg Treated with glycerin compounded 1% lidocaine and epinephrine
Registry intervention entries
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Right leg treated with Glycerin compounded with 1% Lidocaine and Epinephrine
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 30, 2026
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
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).
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).
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
Contact the study team to confirm eligibility.
Phenols
Benzene Derivatives
Hydrocarbons, Aromatic
Hydrocarbons, Cyclic
Hydrocarbons
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 30, 2026
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 15, 2026
Record last verified: 2026-01
Source record
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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