Overview
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.
Description
Telangiectasias and reticular veins are common manifestations of chronic venous disease classified as CEAP C1. Although they are frequently considered primarily aesthetic findings, they may be associated with local symptoms and may negatively affect quality of life and body perception.
Foam sclerotherapy with polidocanol is widely used for the treatment of reticular veins and telangiectasias. However, post-treatment hyperpigmentation, retained thrombi, telangiectatic matting, superficial phlebitis, prolonged ecchymosis, and the need for drainage may occur.
The Cryo-Laser After Foam (CLaF) technique combines polidocanol foam sclerotherapy with subsequent transdermal laser treatment under continuous cold-air cooling. In this technique, polidocanol foam is injected first, followed immediately by application of a long-pulsed 1064-nm Nd:YAG laser over the treated vessels while continuous cold-air cooling is applied to the skin. Foam sclerotherapy remains the primary therapeutic component of the procedure. The proposed rationale is that combining chemical and photothermal mechanisms may enhance vascular occlusion and potentially reduce residual intravascular blood, retained thrombi, and hyperpigmentation, while cold-air cooling provides epidermal protection and improves patient comfort during laser application.
This is a prospective, randomized, controlled, intraindividual, split-leg, assessor-blinded, single-center clinical trial. Seventy women aged 18 to 60 years with bilateral relatively symmetrical CEAP C1 telangiectasias and/or reticular veins will be included. Randomization will determine which lower limb receives CLaF, while the contralateral limb receives isolated polidocanol foam sclerotherapy. Each participant will therefore serve as her own control.
Polidocanol 0.5% foam will constitute the primary sclerosing treatment in both lower limbs. For very small telangiectasias, liquid polidocanol 0.25% may be used as a complementary intravascular microinjection according to the study protocol. The same sclerotherapy criteria will be applied bilaterally.
In the CLaF-treated limb, the Nd:YAG laser will be applied immediately after sclerotherapy under continuous cold-air cooling. For telangiectasias smaller than 1 mm, the laser parameters will be a 2-mm spot size, fluence of 200 J/cm², and pulse duration of 15 ms. For reticular veins measuring 1-3 mm, a 6-mm spot size, fluence of 70 J/cm², and pulse duration of 30 ms will be used. A maximum of 150 laser shots per standardized treatment area is planned.
Treatment will be performed in standardized bilateral 20 × 15 cm areas of the lateral thigh-leg region. Standardized digital photographs and semiautomated image analysis will be used to assess residual vascular area and vascular clearance. Skin pigmentation will also be evaluated clinically, photographically, and instrumentally using a Mexameter®. Additional outcomes will include the Global Aesthetic Improvement Scale (GAIS), pain, retained thrombi, need for drainage, telangiectatic matting, superficial phlebitis, other adverse events, patient satisfaction, and quality of life. Follow-up assessments are planned through 180 days.
Eligibility
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.
