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

5 november 2026 bijgewerkt door: Cecília Salazar Ulacia, University of Sao Paulo

Comparison Between Isolated Foam Sclerotherapy and Foam Sclerotherapy Combined With Transdermal Laser for the Treatment of Reticular Veins and Telangiectasias: A Prospective Randomized Clinical 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

70

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Brazilië
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazilië, 14040-900
        • Werving
        • Clínica Civil - FAEPA USP
        • Contact:
        • Hoofdonderzoeker:
          • Cecília S Ulacia, MD
        • Onderonderzoeker:
          • Mauricio Serra Ribeiro, PHD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 60 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Isolated Foam Sclerotherapy

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
Geneesmiddel: Polidocanol foam sclerotherapy

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.

Andere namen:
  • Polidocanol 0.5% Foam
Experimenteel: Cryo-Laser After Foam (CLaF)

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.
Geneesmiddel: Polidocanol foam sclerotherapy

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.

Andere namen:
  • Polidocanol 0.5% Foam
Apparaat: Transdermal 1064 nm Nd:YAG Laser

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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percent Change in Residual Vascular Area From Baseline to Days 60, 90 and 180
Tijdsspanne: Baseline and Day 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.
Baseline and Day 60,90 and 180

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Vascular Clearance by Blinded Photographic Assessment
Tijdsspanne: Day 60, Day 90, and Day 180

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.
Day 60, Day 90, and Day 180
Global Aesthetic Improvement Scale (GAIS) Score
Tijdsspanne: Day 60, Day 90, and Day 180

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
Day 60, Day 90, and Day 180
Incidence and Intensity of Hyperpigmentation
Tijdsspanne: Day 60, Day 90, and Day 180

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.
Day 60, Day 90, and Day 180
Change in Melanin Index Measured With Mexameter
Tijdsspanne: Baseline, Day 60, Day 90, and Day 180

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.
Baseline, Day 60, Day 90, and Day 180
Incidence of Retained Thrombus and Need for Drainage
Tijdsspanne: Day 21

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.
Day 21
Procedure-Related Pain
Tijdsspanne: Day 0

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
Day 0
Incidence of Telangiectatic Matting, Superficial Phlebitis, Persistent Ecchymosis, Skin Necrosis or Wound, Thromboembolic Events
Tijdsspanne: Day 60, Day 90 and Day 180

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
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
Tijdsspanne: Baseline, Day 90, and Day 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.
Baseline, Day 90, and Day 180
Change in VEINES-QOL Score From Baseline to Days 90 and 180
Tijdsspanne: Baseline, Day 90, and Day 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
Baseline, Day 90, and Day 180
Change in VEINES-Sym Score From Baseline to Days 90 and 180
Tijdsspanne: Baseline, Day 90, and Day 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
Baseline, Day 90, and Day 180

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Patient Treatment Preference
Tijdsspanne: Day 180

At the final follow-up visit, the participant's preference regarding the aesthetic result of the two treated lower limbs will be recorded
Day 180
Need for Retreatment of the Treated Area
Tijdsspanne: Day 180

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
Day 180

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Sao Paulo

Onderzoekers

  • Hoofdonderzoeker: Cecília S Ulacia, MD, University of Sao Paulo

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 september 2026

Primaire voltooiing (Geschat)

1 februari 2027

Studie voltooiing (Geschat)

1 mei 2027

Studieregistratiedata

Eerst ingediend

20 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

26 augustus 2026

Eerst geplaatst (Werkelijk)

28 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 november 2026

Laatste update ingediend die voldeed aan QC-criteria

5 november 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 99535826.1.0000.5440

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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