NCT07793630 Foam Sclerotherapy With or Without Transdermal Laser for Reticular Veins and Telangiectasias
| NCT ID | NCT07793630 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Sao Paulo |
| Condition | Telangiectasias |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2026-09-01 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 70 participants in total. It began in 2026-09-01 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Cecília S Ulacia, MD
PRINCIPAL INVESTIGATOR
University of Sao Paulo
Frequently Asked Questions
Who can join the NCT07793630 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 60 Years, studying Telangiectasias. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07793630 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07793630 currently recruiting?
Yes, NCT07793630 is actively recruiting participants. Contact the research team at ceciliasalazarulacia@usp.br for enrollment information.
Where is the NCT07793630 trial being conducted?
This trial is being conducted at Ribeirão Preto, Brazil.
Who is sponsoring the NCT07793630 clinical trial?
NCT07793630 is sponsored by University of Sao Paulo. The principal investigator is Cecília S Ulacia, MD at University of Sao Paulo. The trial plans to enroll 70 participants.