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

RecruitingPhase 4Ages 18 Years - 60 YearsFemaleUniversity of Sao Paulo
NCT07793630 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This prospective, randomized, controlled, intraindividual split-leg clinical trial will compare isolated polidocanol foam sclerotherapy with the Cryo-Laser After Foam (CLaF) 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 CLaF in one lower limb and isolated foam sclerotherapy in the contralateral limb, with treatment laterality determined by randomization. The CLaF technique consists of polidocanol foam sclerotherapy followed immediately by transdermal 1064-nm Nd:YAG laser under continuous cold-air cooling. The study will evaluate vascular clearance, residual vascular area, hyperpigmentation, retained thrombi and need for drainage, pain, adverse events, aesthetic improvement, patient satisfaction, and quali

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📋 Eligibility rules (as published)
Inclusion Criteria: * Female participants aged 18 to 60 years. * Fitzpatrick skin phototype I, II, or III. * CEAP clinical class C1. * Bilateral relatively symmetrical presence of telangiectasias and reticular veins on the lateral thigh. * Presence of telangiectasias and reticular veins measuring 0.1 to 3 mm in diameter. * Body mass index (BMI) ≤ 30 kg/m² * Willingness to participate in the complete study follow-up and provision of written informed consent. Exclusion Criteria: * Saphenous or perforator venous reflux. * Varicose veins greater than 3 mm in diameter (CEAP C2-C6). * Fitzpatrick skin phototype IV, V, or VI. * Recent venous thrombosis or known thrombophilia. * Use of anticoagulant therapy. * Pregnancy or breastfeeding. * Known allergy to polidocanol. * Peripheral arterial disease with ankle-brachial index (ABI) \< 0.8. * Diabetes mellitus. * Local dermatitis in the treatment area. * Previous venous treatment within the last 6 months. * Failure to attend the treatment session or scheduled follow-up visits.
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What it tests

  • Polidocanol foam sclerotherapy
  • Transdermal 1064 nm Nd:YAG Laser
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Where

1 site
Clínica Civil - FAEPA USP
Ribeirão Preto, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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