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

ConditionLeg Veins
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age20-75
SponsorGoldman, Butterwick, Fitzpatrick and Groff

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Right leg treated with Glycerin compounded with 1% Lidocaine and Epinephrine

    Drug

    Right leg treated with glycerin compounded with 1% lidocaine and epinephrine

  • Left leg treated with Glycerin compounded with 1% Lidocaine and Epinephrine

    Drug

    Left leg treated with glycerin compounded with 1% lidocaine and epinephrine

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Group A Right Leg Treated with glycerin compounded 1% lidocaine and epinephrineActive comparator 1 intervention
Group B: Group B Left Leg Treated with glycerin compounded 1% lidocaine and epinephrineSham comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Goldman, Butterwick, Fitzpatrick and Groff

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: