Low Concentrate Detergents Versus Hypertonic Glucose for the Treatment of Telangiectasia

Derzhavin Tambov State University

Status: Completed

Conditions: Sclerotherapy

Treatments: Procedure: Sclerotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04132323

A001203

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 172 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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172 participants in 4 patient groups

hypertonic glucose

Active Comparator group

Description:

* 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.

Treatment:

Procedure: Sclerotherapy

0.05% sodium tetradecyl sulfate

Active Comparator group

Description:

* 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.

Treatment:

Procedure: Sclerotherapy

0.1% sodium tetradecyl sulfate

Active Comparator group

Description:

* 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.

Treatment:

Procedure: Sclerotherapy

0.15% sodium tetradecyl sulfate

Active Comparator group

Description:

* 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.

Treatment:

Procedure: Sclerotherapy