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NOT YET RECRUITING
NCT07793630
PHASE4

Foam Sclerotherapy With or Without Transdermal Laser for Reticular Veins and Telangiectasias

Sponsor: University of Sao Paulo

View on ClinicalTrials.gov

Summary

his prospective, randomized, controlled, intraindividual split-leg clinical trial will compare isolated polidocanol foam sclerotherapy with the Laser After Foam (LAAF) technique for the treatment of reticular veins and telangiectasias of the lower limbs. The study will include 70 women aged 18 to 60 years with bilateral CEAP C1 telangiectasias and/or reticular veins. Each participant will receive LAAF in one lower limb and isolated foam sclerotherapy in the contralateral limb, with treatment laterality determined by randomization. The study will evaluate vascular clearance, residual vascular area, hyperpigmentation, retained thrombi and need for drainage, pain, adverse events, aesthetic improvement, patient satisfaction, and quality of life during follow-up through 180 days.

Official title: Comparison Between Isolated Foam Sclerotherapy and Foam Sclerotherapy Combined With Transdermal Laser for the Treatment of Reticular Veins and Telangiectasias: A Prospective Randomized Clinical Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2026-08

Completion Date

2027-05

Last Updated

2026-08-28

Healthy Volunteers

No

Interventions

DRUG

Polidocanol foam sclerotherapy

Polidocanol 0.5% foam will be prepared immediately before application using the Tessari technique by mixing 1 mL of 0.5% polidocanol with 4 mL of room air in a 1:4 ratio, using two syringes connected by a three-way stopcock and 20 passages for homogenization. A maximum volume of 2 mL will be used per treated area. Intravascular microinjections will be performed with a fine needle, preferably 27.5G, in fractionated volumes and at a controlled rate. After treatment, standardized light local compression will be maintained for 24 hours.

DEVICE

Transdermal 1064 nm Nd:YAG Laser

Immediately after polidocanol foam sclerotherapy, a long-pulsed transdermal 1064 nm Nd:YAG laser will be applied over the treated foam-filled vessels. Continuous cold-air cooling at approximately -20°C will be used during laser application. Approximately 10% spot overlap, up to two passes over the target vein, and a maximum of 50 shots per treated area will be used unless interruption is required for safety. For telangiectasias smaller than 1 mm, the parameters will be a 2 mm spot, 60 J/cm² fluence, and 15 ms pulse duration. For reticular veins measuring 1-3 mm, the parameters will be a 6 mm spot, 70 J/cm² fluence, and 15 ms pulse duration.

Locations (1)

Clínica Civil - FAEPA USP

Ribeirão Preto, São Paulo, Brazil