NCT07276243

Polidocanol Foam With or Without Transdermal Laser for Varicose Veins: Randomized Clinical Trial

Comparação da eficácia clínica e estética Entre o Tratamento de Varizes Com Espuma de Polidocanol Associada ou não ao Laser transdérmico: Ensaio clínico Randomizado

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Hospital Universitario Pedro Ernesto · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This randomized, double-blind, parallel clinical trial will compare the clinical and aesthetic outcomes of polidocanol foam sclerotherapy alone versus polidocanol foam associated with long-pulse 1064 nm Nd:YAG transdermal laser in the treatment of lower limb tributary varicose veins. The primary endpoint is venous occlusion rate at 30 days assessed by Doppler ultrasound. Secondary outcomes include cutaneous hyperpigmentation, pain, patient satisfaction, and adverse events.

Detailed description

The study aims to evaluate whether the association of transdermal Nd:YAG 1064 nm laser with polidocanol foam improves venous occlusion and aesthetic outcomes compared to foam alone. Participants will be adult patients with lower limb varicose veins CEAP 1-3 confirmed by Doppler ultrasound. After randomization (1:1), the control group will receive 0.5% polidocanol foam, while the intervention group will receive 0.25% polidocanol foam followed by transdermal laser application. A second session will be performed only if partial occlusion persists at the 30-day follow-up. Assessments will include venous occlusion at 30, 90 and 180 days after the procedure, pigmentation, pain intensity, number of sessions required, patient satisfaction, and adverse events. Standardized photographs will be taken at baseline, 30, 90 and 180 days.

Conditions

• Varicose Veins

Interventions

Type	Name	Description
DRUG	Polidocanol foam sclerotherapy	Polidocanol foam prepared using the Tessari method. Concentration 0,5% (Foam Arm) or 0,25% (Foam + Laser Arm), injected under ultrasound guidance.
DEVICE	Transdermal Nd:YAG 1064 nm laser	Long-pulse Nd:YAG 1064 nm transdermal laser applied along the treated vein path immediately after foam injection.

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-08-30
• Completion: 2027-12-30
• First posted: 2025-12-10
• Last updated: 2025-12-10

Locations

1 site across 1 country: Brazil