A Phase 4 interventional study of Polidocanol foam sclerotherapy and Transdermal 1064 nm Nd:YAG Laser in Telangiectasias, Reticular Veins and Chronic Venous Disease, sponsored by University of Sao Paulo. Recruiting at 1 site in Brazil. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by University of Sao Paulo · Phase 4, Interventional, and Treatment
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.
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.
69 studies on the registry are indexed under Telangiectasis; 12 are open to participants now.
This study's planned enrollment of 70 is above the median of 30 across 59 interventional studies indexed under Telangiectasis.
Browse Telangiectasis studies →University of Sao Paulo is the lead sponsor of 1,035 studies on the registry; 95 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The lower limb allocated to the control treatment will receive isolated sclerotherapy with 0.5% polidocanol foam within the standardized treatment area. The contralateral lower limb of the same participant will receive Laser After Foam (LAAF). Treatment laterality will be determined by randomization
Drug: Polidocanol foam sclerotherapy
The lower limb allocated to CLaF will receive 0.5% polidocanol foam sclerotherapy followed immediately by long-pulsed transdermal 1064-nm Nd:YAG laser treatment under continuous cold-air cooling. For very small telangiectasias, 0.25% liquid polidocanol may be used as a complementary intravascular microinjection according to the study protocol. The contralateral lower limb of the same participant will receive isolated polidocanol foam sclerotherapy. Treatment laterality will be determined by randomization.
Drug: Polidocanol foam sclerotherapy · Device: Transdermal 1064 nm Nd:YAG Laser
Polidocanol 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.
Also known as: Polidocanol 0.5% Foam
Immediately 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.
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 180
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 180
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 180
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 180
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 180
Incidence of Retained Thrombus and Need for Drainage
Retained thrombus will be assessed clinically and defined as palpable or visible thrombotic material within the treated venous segment. The presence or absence, approximate size, associated pain, and need for drainage will be recorded. The need for drainage of retained thrombus will be recorded. Drainage may be indicated in the presence of a dark superficial thrombus, painful palpable cord, intravascular nodule, or local pain equal to or greater than 4 on the pain scale, according to the clinical assessor. When performed, the treated limb, date, approximate drained volume, and complications will be recorded.
Time frame: Day 21
Procedure-Related Pain
Pain will be assessed using a numerical rating scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain will be recorded for the sclerotherapy stage, the transdermal laser stage when applicable, and the overall procedure
Time frame: Day 0
Incidence of Telangiectatic Matting, Superficial Phlebitis, Persistent Ecchymosis, Skin Necrosis or Wound, Thromboembolic Events
Telangiectatic matting will be defined as the appearance of new fine network-like telangiectasias within the treated area. Presence or absence and extension of matting will be recorded and compared between treatment techniques. Superficial phlebitis will be assessed clinically based on pain, erythema, and induration along the treated venous segment. Severity and any treatment instituted will be recorded. Persistent ecchymosis will be assessed clinically and defined as ecchymosis persisting beyond the expected post-treatment period or considered clinically relevant during follow-up. Its extent and resolution will be documented. Skin necrosis or wound will be defined as loss of skin integrity within the treated area. When present, lesion dimensions, treatment instituted, and clinical evolution will be recorded. Suspected thromboembolic events, including deep vein thrombosis or pulmonary embolism, will be investigated and recorded. Diagnostic confirmation, clinical management, and notifi
Time frame: Day 60, Day 90 and Day 180
Change in Chronic Venous Insufficiency Questionnaire-14 (CIVIQ-14) Global Index Score From Baseline to Days 90 and 180
Quality of life related to chronic venous disease will be assessed using the Chronic Venous Insufficiency Questionnaire-14 (CIVIQ-14). The questionnaire contains 14 items. Scores will be calculated according to the prespecified scoring method and expressed on a 0 to 100 Global Index Score, with higher scores indicating better quality of life. Change from baseline will be assessed at Day 90 and Day 180. This is a participant-level outcome and will not be attributed separately to either lower limb or intervention.
Time frame: Baseline, Day 90, and Day 180
Change in VEINES-QOL Score From Baseline to Days 90 and 180
Venous disease-specific quality of life will be assessed using the Brazilian Portuguese version of the Venous Insufficiency Epidemiological and Economic Study Quality of Life/Symptoms questionnaire (VEINES-QOL/Sym). The VEINES-QOL score is derived from 25 items included in questions 1, 3, 4, 5, 6, 7, and 8; question 2 is descriptive and is not included in the score. The score will be calculated using intrinsic scoring. After orienting item responses so that higher values indicate a better health status, each item response will be transformed using (i-1)/(k-1), where i is the response category and k is the number of response categories for that item. The mean of the available transformed items will then be multiplied by 100. The VEINES-QOL score ranges from 0 to 100, with higher scores indicating better venous disease-specific quality of life. The score will not be calculated when more than 50% of the relevant items are missing. Change from baseline will be assessed at Day 90 and Day
Time frame: Baseline, Day 90, and Day 180
Change in VEINES-Sym Score From Baseline to Days 90 and 180
Venous symptoms will be assessed using the VEINES-Sym component of the Brazilian Portuguese version of the Venous Insufficiency Epidemiological and Economic Study Quality of Life/Symptoms questionnaire (VEINES-QOL/Sym). The VEINES-Sym score is derived from 10 items: the nine venous symptom items included in question 1 and the leg pain item included in question 7. The score will be calculated using intrinsic scoring. After orienting item responses so that higher values indicate a better health status, each item response will be transformed using (i-1)/(k-1), where i is the response category and k is the number of response categories for that item. The mean of the available transformed items will then be multiplied by 100. The VEINES-Sym score ranges from 0 to 100, with higher scores indicating fewer or less severe venous symptoms and a better symptom status. The score will not be calculated when more than 50% of the relevant items are missing. Change from baseline will be assessed at
Time frame: Baseline, Day 90, and Day 180
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 180
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 180
Plan to share: No — No individual participant data (IPD) sharing is planned under the current study protocol. Participant data will be kept confidential and identified only by an alphanumeric study code. Study results will be reported in aggregate form without identification of individual participants.
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