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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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, 200 J/cm² fluence, and 10-20 ms pulse duration. For reticular veins measuring 1-3 mm, the parameters will be a 6 mm spot, 70 J/cm² fluence, and 30-60 ms pulse duration.

Study 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.

Eligibility

Primary outcome measure(s)

• Percent Change in Residual Vascular Area From Baseline to Days 60, 90 and 180 — Baseline and Day 60,90 and 180
  Residual vascular area will be quantified from standardized digital photographs using semiautomated image analysis, preferably with ImageJ/Fiji, within the standardized 20 × 15 cm treatment area. Change in residual vascular area will be expressed as a percentage relative to baseline at each follow-up time point. The paired intraindividual comparison will be performed between the area treated with Laser After Foam (LAAF) and the contralateral area treated with isolated foam sclerotherapy.

Trial sites (1)

More University of Sao Paulo trials in Brazil

Other trials for the same condition