Foam Sclerotherapy With or Without Transdermal Laser for Reticular Veins and Telangiectasias
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorUniversity of Sao Paulo
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Polidocanol foam sclerotherapy
DrugPolidocanol 0.5% foam will be prepared immediately before application using the Tessari technique by mixing 1 mL of 0.5% polidocanol with 4 mL of room air in a 1:4 ratio, using two syringes connected by a three-way stopcock and approximately 20 passages for homogenization. A maximum foam volume of 2 mL per treated area will be used. Intravascul ar microinjections will be performed with a fine needle, preferably 25G, in fractionated volumes and at a controlled rate. For very small telangiectasias, 0.25% liquid polidocanol may be used as a complementary intravascular microinjection. After treatment, standardized light local compression will be maintained for approximately 24 hours.
Transdermal 1064 nm Nd:YAG Laser
DeviceImmediately after polidocanol sclerotherapy, a long-pulsed transdermal 1064-nm Nd:YAG laser will be applied over the treated vessels under continuous cold-air cooling at approximately -20°C, characterizing the Cryo-Laser After Foam (CLaF) technique. Approximately 10% spot overlap may be used, with up to two passes over the target vessel. A maximum of 150 laser shots per standardized 20 × 15 cm treatment area is planned, unless earlier interruption is required for safety. 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, the parameters will be a 6-mm spot size, fluence of 70 J/cm², and pulse duration of 30 ms. Continuous cold-air cooling will be maintained throughout laser application for epidermal protection and patient comfort.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Isolated Foam SclerotherapyActive comparator 1 intervention
Group B: Cryo-Laser After Foam (CLaF)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Percent Change in Residual Vascular Area From Baseline to Days 60, 90 and 180
Residual vascular area will be quantified from standardized digital photographs using semiautomated image analysis, preferably with ImageJ/Fiji, within the standardized 20 × 15 cm treatment area. Change in residual vascular area will be expressed as a percentage relative to baseline at each follow-up time point. The paired intraindividual comparison will be performed between the area treated with CLaF and the contralateral area treated with isolated foam sclerotherapy.
Time frame
Baseline and Day 60,90 and 180Secondary outcomes
1
Vascular Clearance by Blinded Photographic Assessment
Standardized digital photographs will be independently assessed by two blinded outcome assessors. Vascular clearance will be evaluated by comparing follow-up images with baseline images within the standardized treatment area. In case of clinically relevant disagreement, a third blinded assessor will perform adjudication.
Time frame
Day 60, Day 90, and Day 1802
Global Aesthetic Improvement Scale (GAIS) Score
Global aesthetic improvement will be assessed using the protocol-adapted Global Aesthetic Improvement Scale (GAIS), ranging from -1 to 3. A score of -1 indicates worsening, 0 indicates no change, 1 indicates improvement, 2 indicates marked improvement, and 3 indicates very marked improvement or excellent aesthetic result
Time frame
Day 60, Day 90, and Day 1803
Incidence and Intensity of Hyperpigmentation
Post-treatment hyperpigmentation will be assessed clinically and photographically in the treated area. Hyperpigmentation will be recorded as present or absent and its clinical intensity will be documented. Results will be compared between the ClaF-treated limb and the contralateral limb treated with isolated foam sclerotherapy.
Time frame
Day 60, Day 90, and Day 1804
Change in Melanin Index Measured With Mexameter
Skin pigmentation will be objectively measured using the Mexameter. Standardized measurement points will include the area of greatest pigmentation, when present, and adjacent untreated control skin. Each point will be measured three consecutive times and the arithmetic mean will be used. Change in melanin index will be compared with baseline and adjacent untreated skin.
Time frame
Baseline, Day 60, Day 90, and Day 180Other outcomes
1
Patient Treatment Preference
At the final follow-up visit, the participant's preference regarding the aesthetic result of the two treated lower limbs will be recorded
Time frame
Day 1802
Need for Retreatment of the Treated Area
The need for additional treatment of residual or recurrent reticular veins and telangiectasias within the standardized treated area will be assessed at the final follow-up visit
Time frame
Day 180Sponsors and contacts
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Source ClinicalTrials.gov