Low Concentrate Detergents Versus Hypertonic Glucose for the Treatment of Telangiectasia

Study Overview
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Brief Summary
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Using of low concentrate sodium tetradecyl sulfate for sclerotherapy of telangiectasias should be no less effective than hypertonic glucose, and have a comparable frequency of adverse events.

Detailed Description
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For sclerotherapy of telangiectasias are used detergents. These are aggressive substances, which have a high frequency of adverse events. According to histological studies the safest concentration for the treatment of telangiectasias is less than that specified in the official instructions. The concentration of sodium tetradecyl sulfate 0.15% was effective and did not cause any adverse reactions in the treatment of telangiectasias from 0.8 to 1 mm in diameter. Small telangiectases (0.5 mm or less) require the treatment with the less aggressive sclerosing agent. Perhaps, the sodium tetradecyl sulfate 0.15%, 0.1% or even 0.05% and hypertonic glucose may be more effective and safe in this situation.

Official Title
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Clinical Efficacy of Low Concentrate Detergents Versus Hypertonic Glucose for the Treatment of Telangiectasia: a Prospective Randomized Clinical Trial

Conditions
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Sclerotherapy

Intervention / Treatment
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* Procedure: Sclerotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women over 18 single primary or secondary telangiectasias unrelated to the reticular veins signed informed consent to participate in the study Exclusion Criteria: telangiectasias associated with reticular veins diabetes mellitus pregnancy or lactation malignant neoplasms inability or unwillingness of the patient to wear compression stockings hypersensitivity to one of the drugs 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
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: hypertonic glucose<br>to take photo of problem area in the patient's standing position in the room with artificial lighting using the iPhone 6s and above, Samsung Galaxy S7 and above from a distance of 20 cm. to measure the maximum diameter of telangiectasia using the Dermatoscope scale. to inject the 75% glucose, with a 2 ml luer-lock syringe through 30 G needle in telangiectasia until the vessel disappears. | Procedure: Sclerotherapy<br>* Examination, photographing, inclusion in the study, signing of informed consent, randomization, diameter measurement, sclerotherapy according to the randomization group<br>|
| Active Comparator: 0.05% sodium tetradecyl sulfate<br>to take photo of problem area in the patient's standing position in the room with artificial lighting using the iPhone 6s and above, Samsung Galaxy S7 and above from a distance of 20 cm. to measure the maximum diameter of telangiectasia using the Dermatoscope scale. to inject the 0.05% sodium tetradecyl sulfate with a 2 ml luer-lock syringe through 30 G needle in telangiectasia until the vessel disappears. | Procedure: Sclerotherapy<br>* Examination, photographing, inclusion in the study, signing of informed consent, randomization, diameter measurement, sclerotherapy according to the randomization group<br>|
| Active Comparator: 0.1% sodium tetradecyl sulfate<br>to take photo of problem area in the patient's standing position in the room with artificial lighting using the iPhone 6s and above, Samsung Galaxy S7 and above from a distance of 20 cm. to measure the maximum diameter of telangiectasia using the Dermatoscope scale. to inject the 0.1% sodium tetradecyl sulfate with a 2 ml luer-lock syringe through 30 G needle in telangiectasia until the vessel disappears. | Procedure: Sclerotherapy<br>* Examination, photographing, inclusion in the study, signing of informed consent, randomization, diameter measurement, sclerotherapy according to the randomization group<br>|
| Active Comparator: 0.15% sodium tetradecyl sulfate<br>to take photo of problem area in the patient's standing position in the room with artificial lighting using the iPhone 6s and above, Samsung Galaxy S7 and above from a distance of 20 cm. to measure the maximum diameter of telangiectasia using the Dermatoscope scale. to inject the 0.15% sodium tetradecyl sulfate with a 2 ml luer-lock syringe through 30 G needle in telangiectasia until the vessel disappears. | Procedure: Sclerotherapy<br>* Examination, photographing, inclusion in the study, signing of informed consent, randomization, diameter measurement, sclerotherapy according to the randomization group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disappearance of the telangiectasia | 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. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain during the procedure: visual analog scale | Estimate of the pain on visual analog scale. Visual analog scale [VAS] is a measure of pain intensity. It is a continuous scale comprised of a horizontal 10 cm length: no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 10). | 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) | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sclerotherapy, hypertonic glucose, sodium tetradecyl sulfate