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Completed

NCT Number: NCT04132323

Low Concentrate Detergents Versus Hypertonic Glucose for the Treatment of Telangiectasia

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.

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Key information

Conditions

Sclerotherapy

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bukina Oksana Vasilyevna

Tambov, 392014, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Sclerotherapy

Procedure

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

Primary outcomes

  1. Disappearance of the telangiectasia

    Time frame: 2 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: visual analog scale

    Time frame: immediately after the procedure

    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).

  2. Patient Satisfaction After Treatment

    Time frame: 2 months

    Assessment of patient satisfaction on the 3-point scale :

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

Sponsors and collaborators

Lead sponsor

Derzhavin Tambov State University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 18, 2019
Registry last updated
Oct 10, 2023

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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