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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Right leg treated with Glycerin compounded with 1% Lidocaine and Epinephrine | Drug | Right leg treated with glycerin compounded with 1% lidocaine and epinephrine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physician Global Aesthetic Improvement Scale PGAIS | Please rate right leg veins: Circle One
Please rate left leg veins: Circle One
| Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction Likert Score for vein improvement | Please rate right leg veins: Circle One
Please rate left leg veins: Circle One
| Day 90 |
| Visual Analog Pain Scale Post Treatment |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Pacheco | Contact | 858-657-1004 | apacheco@clderm.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Dermatology Research Center | San Diego | California | 92121 | United States |
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| Left leg treated with Glycerin compounded with 1% Lidocaine and Epinephrine | Drug | Left leg treated with glycerin compounded with 1% lidocaine and epinephrine |
|
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 |
| Day 1 and Day 30 |
| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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