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

NCT07793630 | Not Yet Recruiting Phase 4

• 1 other identifier: 99535826.1.0000.5440
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

his prospective, randomized, controlled, intraindividual split-leg clinical trial will compare isolated polidocanol foam sclerotherapy with the Laser After Foam (LAAF) 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 LAAF in one lower limb and isolated foam sclerotherapy in the contralateral limb, with treatment laterality determined by randomization. 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.

Conditions

Telangiectasias; Reticular Veins; Chronic Venous Disease

Keywords

CEAP C1; Foam Sclerotherapy; Polidocanol; Laser After Foam; Nd:YAG Laser; LAAF; Hyperpigmentation

Outcome Measures

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 Laser After Foam (LAAF) and the contralateral area treated with isolated foam sclerotherapy.

  Baseline and Day 60,90 and 180

Secondary Outcomes (10)

• Vascular Clearance by Blinded Photographic Assessment

  Day 60, Day 90, and Day 180

• Global Aesthetic Improvement Scale (GAIS) Score

  Day 60, Day 90, and Day 180

• Incidence and Intensity of Hyperpigmentation

  Day 60, Day 90, and Day 180

• Change in Melanin Index Measured With Mexameter

  Baseline, Day 60, Day 90, and Day 180

• Incidence of Retained Thrombus and Need for Drainage

  Day 21

Other Outcomes (2)

• Patient Treatment Preference

  Day 180

• Need for Retreatment of the Treated Area

  Day 180

Study Arms (2)

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

Drug: Polidocanol foam sclerotherapy

Laser After Foam (LAAF)

EXPERIMENTAL

The lower limb allocated to LAAF will receive 0.5% polidocanol foam sclerotherapy followed immediately by long-pulsed transdermal 1064 nm Nd:YAG laser treatment over the treated foam-filled vessels. The contralateral lower limb of the same participant will receive isolated foam sclerotherapy

Drug: Polidocanol foam sclerotherapy; Device: Transdermal 1064 nm Nd:YAG Laser

Interventions

Polidocanol foam sclerotherapy DRUG

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 20 passages for homogenization. A maximum volume of 2 mL will be used per treated area. Intravascular microinjections will be performed with a fine needle, preferably 27.5G, in fractionated volumes and at a controlled rate. After treatment, standardized light local compression will be maintained for 24 hours.

Also known as: Polidocanol 0.5% Foam

Isolated Foam Sclerotherapy; Laser After Foam (LAAF)

Transdermal 1064 nm Nd:YAG Laser DEVICE

Immediately after polidocanol foam sclerotherapy, a long-pulsed transdermal 1064 nm Nd:YAG laser will be applied over the treated foam-filled vessels. Continuous cold-air cooling at approximately -20°C will be used during laser application. Approximately 10% spot overlap, up to two passes over the target vein, and a maximum of 50 shots per treated area will be used unless interruption is required for safety. For telangiectasias smaller than 1 mm, the parameters will be a 2 mm spot, 60 J/cm² fluence, and 15 ms pulse duration. For reticular veins measuring 1-3 mm, the parameters will be a 6 mm spot, 70 J/cm² fluence, and 15 ms pulse duration.

Laser After Foam (LAAF)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Willingness to participate in the complete study follow-up and provision of written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Clínica Civil - FAEPA USP

Ribeirão Preto, São Paulo, 14040-900, Brazil

Location

Related Publications (9)

• 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.

  PMID: 31839797 BACKGROUND

• 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.

  PMID: 30707327 BACKGROUND

• 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.

  PMID: 22886138 BACKGROUND

• 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.

  PMID: 23989971 BACKGROUND

• 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.

  PMID: 11231246 BACKGROUND

• 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.

  PMID: 34637138 BACKGROUND

• 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.

  PMID: 39027725 BACKGROUND

• 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.

  PMID: 32778489 BACKGROUND

• 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.

  PMID: 28973414 BACKGROUND

MeSH Terms

Conditions

Telangiectasis; Hyperpigmentation

Interventions

Polidocanol; Administration, Cutaneous

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Administration, Topical; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Cecília S Ulacia, MD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cecília S Ulacia, MD

CONTACT

+55 (16) 3963-6500; ceciliasalazarulacia@usp.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The operator cannot be blinded due to the nature of the interventions. Participants will receive standardized instructions not to disclose to the outcome assessors which lower limb received laser treatment. Outcome assessors will be blinded to treatment allocation and laterality. Standardized photographs will be coded and presented without identification of the treated limb, treatment date, or intervention. Two independent assessors will evaluate the images separately. In case of clinically relevant disagreement, a third blinded assessor will perform adjudication.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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 Laser After Foam (LAAF); the contralateral lower limb receives isolated polidocanol foam sclerotherapy. Each participant therefore serves as her own control

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 28, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)