Laser Treatment of Reticular Leg Veins vs. Sclerotherapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Reticular Leg Veins

Intervention / Treatment
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* Procedure: Laser ablation
* Procedure: Laser with Sclerotherapy
* Procedure: Sclerotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laser<br>to take photo of problem area in the patient's standing position in the room with artificial lighting using the Canon SX510 HS from a distance of 50 cm. to measure the maximum diameter of telangiectasia using the Ultrasound Mindray M7 . to treat the reticular vein by the Nd:YAG laser with a wavelength of 1064 nm, a 7 mm spot, pulse length of 50 msec and fluency 140 J/cm2 | Procedure: Laser ablation<br>* Examination, photographing, inclusion in the study, signing of informed consent, randomization, diameter measurement, laser<br>|
| Active Comparator: Laser with Sclerotherapy<br>to take photo of problem area in the patient's standing position in the room with artificial lighting using the Canon SX510 HS from a distance of 50 cm. to measure the maximum diameter of telangiectasia using the Ultrasound Mindray M7 . to treat the reticular vein by the Nd:YAG laser with a wavelength of 1064 nm, a 7 mm spot, pulse length of 15 msec and fluency 70 J/cm2 to inject the 0.3% foam polidocanol with a 5 ml luer-lock syringe through 30 G needle into reticular vein until the vessel disappears. | Procedure: Laser with Sclerotherapy<br>* Examination, photographing, inclusion in the study, signing of informed consent, randomization, diameter measurement, laser plus sclerotherapy<br>|
| Active Comparator: Sclerotherapy<br>to take photo of problem area in the patient's standing position in the room with artificial lighting using the Canon SX510 HS from a distance of 50 cm. to measure the maximum diameter of telangiectasia using the Ultrasound Mindray M7 . to inject the 0.5% foam polidocanol with a 5 ml luer-lock syringe through 30 G needle into reticular vein until the vessel disappears. | Procedure: Sclerotherapy<br>* Examination, photographing, inclusion in the study, signing of informed consent, randomization, diameter measurement, sclerotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disappearance of the reticular vein | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain during the procedure: Numerical Rating Scale | Estimate of the pain on Numerical Rating Scale. Numerical Rating Scale [NRS] is a measure of pain intensity from 0 to 10 points. | immediately after the procedure | 
| Patient Satisfaction After Treatment | Assessment of patient satisfaction on the 3-point scale : no result (0 points), incomplete satisfaction (1 point), complete satisfaction (2 points) | 6 months | 
| Intensity of hyperpigmentation | Assessment of Intensity of hyperpigmentation on Skin Hyperpigmentation Index (SHI) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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reticular veins, long-pulsed Nd:YAG laser, sclerotherapy