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

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment reopened Eligibility criteria expanded, about 19 words · Secondary endpoints: details revised at 9 of 10 entries · Study description expanded, about 161 words · 2 more Show 5 more changesShow less
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 9 of 10 entries
    • Study description expanded, about 161 words
    • Site details revised
    • Publications: details revised at 8 of 9 entries
  2. Trial status changed: Not Yet Recruiting → Active, Not Recruiting Start date changed from estimate of Aug 2026 to Sep 1, 2026 · Eligibility criteria expanded, about 7 words · Site contact updatedv2 Show 3 more changesShow less
    • Start date changed from estimate of Aug 2026 to Sep 1, 2026
    • Eligibility criteria expanded, about 7 words
    • Site contact updated

    See this version in full on ClinicalTrials.gov ↗

  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 quality of life during follow-up through 180 days.
Trial Details
NCT Number NCT07793630
Lead Sponsor University of Sao Paulo
Conditions Telangiectasias, Reticular Veins, Chronic Venous Disease
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov