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

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

Treatments tested in this trial

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

Treatment groups

20 Participants
are divided into 2 treatment groups