TelangiectasiasPhase 4NCT07793630

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

A Phase 4 study testing Polidocanol foam sclerotherapy and Transdermal 1064 nm Nd:YAG Laser in people with Telangiectasias and Reticular Veins, run by University of Sao Paulo at 1 site in Brazil.

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Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 60 years, women only
Conditions the study is for: Telangiectasias, Reticular Veins, Chronic Venous Disease
What is being tested?: Polidocanol foam sclerotherapy and Transdermal 1064 nm Nd:YAG Laser
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteBrazil
Study dates: 1 Sep 2026to May 2027
Phase: Phase 4
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
Women only
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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.

Show all 12Show fewer

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Cecília S Ulacia, MD contact

+55 (16) 3963-6500

ceciliasalazarulacia@usp.br

Brazil1 site, 1 recruiting

Clínica Civil - FAEPA USP
Ribeirão Preto, São Paulo, 14040-900
Cecília S Ulacia, MD, (16) 3963-6500, ceciliasalazarulacia@usp.br
Cecília S Ulacia, MD
Recruiting

Other trials in Brazil

About this study

Official title: 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.

Read the detailed 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.

Conditions: Telangiectasias, Reticular Veins, Chronic Venous Disease
Being tested: Polidocanol foam sclerotherapy, Transdermal 1064 nm Nd:YAG Laser
Keywords: CEAP C1, Foam Sclerotherapy, Polidocanol, Laser After Foam, Nd:YAG Laser, LAAF, Hyperpigmentation
Medical subject headings: Telangiectasis, Hyperpigmentation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Polidocanol foam sclerotherapyDrug
Also called Polidocanol 0.5% Foam
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.
Transdermal 1064 nm Nd:YAG LaserDevice
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.

Study groups in NCT07793630
Study group	Role	What they receive
Isolated Foam Sclerotherapy	Active comparator	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 Receives: Drug: Polidocanol foam sclerotherapy
Cryo-Laser After Foam (CLaF)	Experimental	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. Receives: Drug: Polidocanol foam sclerotherapy; Device: Transdermal 1064 nm Nd:YAG Laser

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and Day 60,90 and 180

Secondary outcomes (10)

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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: Baseline, Day 90, and Day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 2026May 2027

First posted28 Aug 2026
Study start1 Sep 2026
Primary completionFeb 2027 (estimated)
Study completionMay 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for TelangiectasiasStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Intraindividual split-leg design. Each participant receives both study interventions in standardized contralateral lower-limb treatment areas. Randomization in a 1:1 ratio determines which lower limb receives CLaF; the contralateral lower limb receives isolated polidocanol foam sclerotherapy. Each participant therefore serves as her own control
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 70 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07793630
Sponsor's protocol ID: 99535826.1.0000.5440
Status last verified: Oct 2026
First submitted: 20 Aug 2026
Last updated: 5 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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.

Publications

Ribeiro-Samora GA, Carvalho MLV, de Moura RMF, Pereira DAG. Limitations of VEINES QOL/SYM for discriminating chronic venous insufficiency severity. J Vasc Bras. 2019 Nov 29;19:e20180096. doi: 10.1590/1677-5449.180096.
PubMed 31839797
Moreno-Moraga J, Pascu ML, Alcolea JM, Smarandache A, Royo J, David F, Trelles MA. Effects of 1064-nm Nd:YAG long-pulse laser on polidocanol microfoam injected for varicose vein treatment: a controlled observational study of 404 legs, after 5-year-long treatment. Lasers Med Sci. 2019 Sep;34(7):1325-1332. doi: 10.1007/s10103-019-02736-1. Epub 2019 Feb 1.
PubMed 30707327
Moreno-Moraga J, Hernandez E, Royo J, Alcolea J, Isarria MJ, Pascu ML, Smarandache A, Trelles M. Optimal and safe treatment of spider leg veins measuring less than 1.5 mm on skin type IV patients, using repeated low-fluence Nd:YAG laser pulses after polidocanol injection. Lasers Med Sci. 2013 May;28(3):925-33. doi: 10.1007/s10103-012-1180-6. Epub 2012 Aug 11.
PubMed 22886138
Moreno-Moraga J, Smarandache A, Pascu ML, Royo J, Trelles MA. 1064 nm Nd:YAG long pulse laser after polidocanol microfoam injection dramatically improves the result of leg vein treatment: a randomized controlled trial on 517 legs with a three-year follow-up. Phlebology. 2014 Dec;29(10):658-66. doi: 10.1177/0268355513502786. Epub 2013 Aug 29.
PubMed 23989971
Tessari L, Cavezzi A, Frullini A. Preliminary experience with a new sclerosing foam in the treatment of varicose veins. Dermatol Surg. 2001 Jan;27(1):58-60.
PubMed 11231246
Nakano LC, Cacione DG, Baptista-Silva JC, Flumignan RL. Treatment for telangiectasias and reticular veins. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD012723. doi: 10.1002/14651858.CD012723.pub2.
PubMed 34637138
Fonseca MM, Mocelin FJ, Poltronieri LR, Guimaraes Filho JL. Treatment of varicose veins using the Cryo laser after foam technique. J Vasc Surg Cases Innov Tech. 2024 May 29;10(4):101549. doi: 10.1016/j.jvscit.2024.101549. eCollection 2024 Aug.
PubMed 39027725
Bertanha M, Yoshida WB, Bueno de Camargo PA, Moura R, Reis de Paula D, Padovani CR, Sobreira ML. Polidocanol Plus Glucose Versus Glucose Alone for the Treatment of Telangiectasias: Triple Blind, Randomised Controlled Trial (PG3T). Eur J Vasc Endovasc Surg. 2021 Jan;61(1):128-135. doi: 10.1016/j.ejvs.2020.07.007. Epub 2020 Aug 7.
PubMed 32778489
Bertanha M, Jaldin RG, Moura R, Pimenta REF, Mariuba JVO, Lucio Filho CEP, Alcantara GP, Padovani CR, Yoshida WB, Sobreira ML. Sclerotherapy for Reticular Veins in the Lower Limbs: A Triple-Blind Randomized Clinical Trial. JAMA Dermatol. 2017 Dec 1;153(12):1249-1255. doi: 10.1001/jamadermatol.2017.3426.
PubMed 28973414

Interested in taking part?

Cecília S Ulacia, MD

+55 (16) 3963-6500

ceciliasalazarulacia@usp.br

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT07793630
Acronym / sponsor ID: 99535826.1.0000.5440
Conditions: Telangiectasias, Reticular Veins, Chronic Venous Disease
Keywords: CEAP C1, Foam Sclerotherapy, Polidocanol, Laser After Foam, Nd:YAG Laser, LAAF, Hyperpigmentation
Phase: Phase 4
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 70 participants (estimated)
Lead sponsor: University of Sao PauloUniversity, hospital or other
Study start: 1 Sep 2026 (actual)
Primary completion: Feb 2027 (estimated)
Study completion: May 2027 (estimated)
First posted: 28 Aug 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Intraindividual split-leg design. Each participant receives both study interventions in standardized contralateral lower-limb treatment areas. Randomization in a 1:1 ratio determines which lower limb receives CLaF; the contralateral lower limb receives isolated polidocanol foam sclerotherapy. Each participant therefore serves as her own control

Arm	Type	Receives
Isolated Foam Sclerotherapy	Active comparator	Drug: Polidocanol foam sclerotherapyThe 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
Cryo-Laser After Foam (CLaF)	Experimental	Drug: Polidocanol foam sclerotherapy, Device: Transdermal 1064 nm Nd:YAG LaserThe 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.

Who may qualify

Ages: 18 to 60 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (12 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Polidocanol foam sclerotherapyAlso: Polidocanol 0.5% FoamPolidocanol 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.	Drug	Cryo-Laser After Foam (CLaF), Isolated Foam Sclerotherapy
Transdermal 1064 nm Nd:YAG LaserImmediately 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.	Device	Cryo-Laser After Foam (CLaF)

Primary outcome

Percent Change in Residual Vascular Area From Baseline to Days 60, 90 and 180
Time frame: 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.

10 secondary outcomes

Vascular Clearance by Blinded Photographic Assessment
Time frame: Day 60, Day 90, and Day 180
Global Aesthetic Improvement Scale (GAIS) Score
Time frame: Day 60, Day 90, and Day 180
Incidence and Intensity of Hyperpigmentation
Time frame: Day 60, Day 90, and Day 180
Change in Melanin Index Measured With Mexameter
Time frame: Baseline, Day 60, Day 90, and Day 180
Incidence of Retained Thrombus and Need for Drainage
Time frame: Day 21
Procedure-Related Pain
Time frame: Day 0
Incidence of Telangiectatic Matting, Superficial Phlebitis, Persistent Ecchymosis, Skin Necrosis or Wound, Thromboembolic Events
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
Time frame: Baseline, Day 90, and Day 180
Change in VEINES-QOL Score From Baseline to Days 90 and 180
Time frame: Baseline, Day 90, and Day 180
Change in VEINES-Sym Score From Baseline to Days 90 and 180
Time frame: Baseline, Day 90, and Day 180

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
Background: PubMed 31839797Ribeiro-Samora GA, Carvalho MLV, de Moura RMF, Pereira DAG. Limitations of VEINES QOL/SYM for discriminating chronic venous insufficiency severity. J Vasc Bras. 2019 Nov 29;19:e20180096. doi: 10.1590/1677-5449.180096.
Background: PubMed 30707327Moreno-Moraga J, Pascu ML, Alcolea JM, Smarandache A, Royo J, David F, Trelles MA. Effects of 1064-nm Nd:YAG long-pulse laser on polidocanol microfoam injected for varicose vein treatment: a controlled observational study of 404 legs, after 5-year-long treatment. Lasers Med Sci. 2019 Sep;34(7):1325-1332. doi: 10.1007/s10103-019-02736-1. Epub 2019 Feb 1.
Background: PubMed 22886138Moreno-Moraga J, Hernandez E, Royo J, Alcolea J, Isarria MJ, Pascu ML, Smarandache A, Trelles M. Optimal and safe treatment of spider leg veins measuring less than 1.5 mm on skin type IV patients, using repeated low-fluence Nd:YAG laser pulses after polidocanol injection. Lasers Med Sci. 2013 May;28(3):925-33. doi: 10.1007/s10103-012-1180-6. Epub 2012 Aug 11.
Background: PubMed 23989971Moreno-Moraga J, Smarandache A, Pascu ML, Royo J, Trelles MA. 1064 nm Nd:YAG long pulse laser after polidocanol microfoam injection dramatically improves the result of leg vein treatment: a randomized controlled trial on 517 legs with a three-year follow-up. Phlebology. 2014 Dec;29(10):658-66. doi: 10.1177/0268355513502786. Epub 2013 Aug 29.
Background: PubMed 11231246Tessari L, Cavezzi A, Frullini A. Preliminary experience with a new sclerosing foam in the treatment of varicose veins. Dermatol Surg. 2001 Jan;27(1):58-60.
Background: PubMed 34637138Nakano LC, Cacione DG, Baptista-Silva JC, Flumignan RL. Treatment for telangiectasias and reticular veins. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD012723. doi: 10.1002/14651858.CD012723.pub2.
Background: PubMed 39027725Fonseca MM, Mocelin FJ, Poltronieri LR, Guimaraes Filho JL. Treatment of varicose veins using the Cryo laser after foam technique. J Vasc Surg Cases Innov Tech. 2024 May 29;10(4):101549. doi: 10.1016/j.jvscit.2024.101549. eCollection 2024 Aug.
Background: PubMed 32778489Bertanha M, Yoshida WB, Bueno de Camargo PA, Moura R, Reis de Paula D, Padovani CR, Sobreira ML. Polidocanol Plus Glucose Versus Glucose Alone for the Treatment of Telangiectasias: Triple Blind, Randomised Controlled Trial (PG3T). Eur J Vasc Endovasc Surg. 2021 Jan;61(1):128-135. doi: 10.1016/j.ejvs.2020.07.007. Epub 2020 Aug 7.
Background: PubMed 28973414Bertanha M, Jaldin RG, Moura R, Pimenta REF, Mariuba JVO, Lucio Filho CEP, Alcantara GP, Padovani CR, Yoshida WB, Sobreira ML. Sclerotherapy for Reticular Veins in the Lower Limbs: A Triple-Blind Randomized Clinical Trial. JAMA Dermatol. 2017 Dec 1;153(12):1249-1255. doi: 10.1001/jamadermatol.2017.3426.
Individual participant dataSharing planned: 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Cecília S Ulacia, MD contact

+55 (16) 3963-6500

ceciliasalazarulacia@usp.br

Cecília S Ulacia, MD principal investigator

University of Sao Paulo

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Polidocanol foam sclerotherapy and Transdermal 1064 nm Nd:YAG Laser in people with Telangiectasias and Reticular Veins, run by University of Sao Paulo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cecília S Ulacia, MD (+55 (16) 3963-6500, ceciliasalazarulacia@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change in Residual Vascular Area From Baseline to Days 60, 90 and 180 (time frame: Baseline and Day 60,90 and 180). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07793630, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.