Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Active Not Recruiting NCT07793630

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

Conditions: Telangiectasias, Reticular Veins, Chronic Venous Disease

Sex: Female
Ages: 18 Years – 60 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 70
Sponsor: University of Sao Paulo

Location: Clínica Civil - FAEPA USP Ribeirão Preto São Paulo

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 Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07793630). StuddyBuddy aggregates publicly available trial information.