Low Concentrate Detergents Versus Hypertonic Glucose for the Treatment of Telangiectasia

October 7, 2023 updated by: Oksana Bukina, Derzhavin Tambov State University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

172

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: hypertonic glucose
  • 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
Examination, photographing, inclusion in the study, signing of informed consent, randomization, diameter measurement, sclerotherapy according to the randomization group
Active Comparator: 0.05% sodium tetradecyl sulfate
  • 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
Examination, photographing, inclusion in the study, signing of informed consent, randomization, diameter measurement, sclerotherapy according to the randomization group
Active Comparator: 0.1% sodium tetradecyl sulfate
  • 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
Examination, photographing, inclusion in the study, signing of informed consent, randomization, diameter measurement, sclerotherapy according to the randomization group
Active Comparator: 0.15% sodium tetradecyl sulfate
  • 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
Examination, photographing, inclusion in the study, signing of informed consent, randomization, diameter measurement, sclerotherapy according to the randomization group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
immediately after the procedure
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)
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Derzhavin Tambov State University

Investigators

  • Principal Investigator: Oksana Bukina, PhD, Derzhavin Tambov State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2019

Primary Completion (Actual)

March 15, 2022

Study Completion (Actual)

March 15, 2022

Study Registration Dates

First Submitted

October 16, 2019

First Submitted That Met QC Criteria

October 17, 2019

First Posted (Actual)

October 18, 2019

Study Record Updates

Last Update Posted (Actual)

October 10, 2023

Last Update Submitted That Met QC Criteria

October 7, 2023

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A001203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study data are available to all investigators in the chronic vein disease registry.

IPD Sharing Time Frame

From 25 October 2019 to 25 December 2021

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Study Data/Documents

  1. Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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