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NCT Number: NCT06175754

Laser Treatment of Reticular Leg Veins vs. Sclerotherapy

Treatment of reticular veins with a 1064 nm long-pulsed Nd:YAG laser and combination of a 1064 nm Nd:YAG long pulse laser and sclerotherapy should be no less effective than sclerotherapy alone, and have a frequency of adverse events less then sclerotherapy alone.

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Key information

Conditions

Reticular Leg Veins

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Reticular leg veins are mostly an aesthetic problem. Sclerotherapy is considered the gold standard for treatment them. However, this method has a high frequency of long persistent hyperpigmentation which decreases the patients' satisfaction. It is a reason to find another method of treatment. Another possible technique to treat reticular veins is the Nd:YAG long pulse 1064 nm transdermal laser or Nd:YAG laser combined with injection sclerotherapy. There are a few studies comparing sclerotherapy with laser treatment and combined treatment with sclerotherapy. But there are no prospective, randomized, comparative clinical trials of all three methods: the 1064 nm Nd:YAG long pulse laser, combined treatment of a 1064 nm Nd:YAG long pulse laser with sclerotherapy and sclerotherapy alone. The aim of current study is the efficacy assessment of the 1064 nm long-pulsed Nd:YAG laser, combined treatment of the 1064 nm Nd:YAG long pulse laser with sclerotherapy and sclerotherapy alone for the treatment of reticular leg veins and analysis of side effects to establish advantages and disadvantage of these methods and find the best option for treatment of reticular leg veins.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • women over 18
  • reticular veins
  • signed informed consent to participate in the study

Exclusion criteria

  • diabetes mellitus
  • pregnancy or lactation
  • malignant neoplasms
  • inability or unwillingness of the patient to wear compression stockings
  • hypersensitivity to the polidocanol, cold, sunlight
  • concomitant diseases: bronchial asthma, severe liver and kidney disease, acute thrombosis and thrombophlebitis, infection of the skin and/or soft tissues, infectious diseases, arteriosclerosis, diabetic angiopathy, heart defects requiring surgery, fever, toxic hyperthyroidism, obesity, tuberculosis, sepsis, violation of the cellular composition of the blood, all diseases requiring bed rest, heart disease with decompensation phenomena,
  • known hereditary thrombophilia.
  • period after treatment of alcoholism
  • reception of oral contraceptives
  • sedentary lifestyle

Treatment and study plan

Laser ablation

Procedure

Examination, photographing, inclusion in the study, signing of informed consent, randomization, diameter measurement, laser

Laser with Sclerotherapy

Procedure

Examination, photographing, inclusion in the study, signing of informed consent, randomization, diameter measurement, laser plus sclerotherapy

Sclerotherapy

Procedure

Examination, photographing, inclusion in the study, signing of informed consent, randomization, diameter measurement, sclerotherapy

Primary outcomes

  1. Disappearance of the reticular vein

    Time frame: 6 months

    The clearing of the vessels on the six-point scale (from 0 to 5 points): 5 - total disappearance of the matting (100% efficacy), 4 - disappearance of around 80%, 3 - disappearance of around 60%, 2 - disappearance of around 40%, 1 - disappearance of around 20%, 0 - no changes.

Secondary outcomes

  1. Pain during the procedure: Numerical Rating Scale

    Time frame: immediately after the procedure

    Estimate of the pain on Numerical Rating Scale. Numerical Rating Scale [NRS] is a measure of pain intensity from 0 to 10 points.

  2. Patient Satisfaction After Treatment

    Time frame: 6 months

    Assessment of patient satisfaction on the 3-point scale :

    no result (0 points), incomplete satisfaction (1 point), complete satisfaction (2 points)

  3. Intensity of hyperpigmentation

    Time frame: 6 months

    Assessment of Intensity of hyperpigmentation on Skin Hyperpigmentation Index (SHI)

Study contacts

Contact information is provided by the study sponsor or research team.

Gusen I Kurbanov

CONTACT

[email protected]

+79622348861

Oksana V Bukina, PhD

CONTACT

[email protected]

+79051204983

Sponsors and collaborators

Lead sponsor

Derzhavin Tambov State University

Other

Registry information

Official study title

Treatment of Reticular Leg Veins: a Prospective, Randomized, Comparative Clinical Trial of a 1064 nm Nd:YAG Long Pulse Laser, Combined Treatment of a 1064 nm Nd:YAG Long Pulse Laser and Sclerotherapy vs. Sclerotherapy Alone.

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 19, 2023
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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