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

NCT07793630 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-08-28

No results posted yet for this 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.

Conditions

  • Telangiectasias
  • Reticular Veins
  • Chronic Venous Disease

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.

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Cecília S Ulacia, MD · University of Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-02-28
Completion
2027-05-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07793630 on ClinicalTrials.gov