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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Right leg treated with Glycerin compounded with 1% Lidocaine and Epinephrine
  Right leg treated with glycerin compounded with 1% lidocaine and epinephrine
• Препарат Left leg treated with Glycerin compounded with 1% Lidocaine and Epinephrine
  Left leg treated with glycerin compounded with 1% lidocaine and epinephrine

Первичные конечные точки

• Physician Global Aesthetic Improvement Scale PGAIS [Срок оценки: Day 90]

Вторичные конечные точки (2)

• Patient Satisfaction Likert Score for vein improvement [Срок оценки: Day 90]
• Visual Analog Pain Scale Post Treatment [Срок оценки: Day 1 and Day 30]

Критерии участия

Критерии включения

• 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.
• 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).

Критерии исключения

• 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).
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• West Dermatology Research Center — San Diego

Идентификаторы

NCT: NCT07342413 · Sclero-Epi-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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