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Low Concentrate Detergents Versus Hypertonic Glucose for the Treatment of Telangiectasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04132323
Recruitment Status : Not yet recruiting
First Posted : October 18, 2019
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
Oksana Bukina, Derzhavin Tambov State University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sclerotherapy Procedure: Sclerotherapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Efficacy of Low Concentrate Detergents Versus Hypertonic Glucose for the Treatment of Telangiectasia: a Prospective Randomized Clinical Trial
Estimated Study Start Date : October 25, 2019
Estimated Primary Completion Date : July 15, 2020
Estimated Study Completion Date : September 15, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04132323


Contacts
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Contact: Oksana V Bukina, PhD +79051204983 ovsafonova@yandex.ru
Contact: Alexander A Sinitsyn +79202670286 dr.sinicin@mail.ru

Locations
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Russian Federation
Bukina Oksana Vasilyevna
Tambov, Russian Federation, 392014
Contact: Oksana V Bukina, PhD    +79051204983    ovsafonova@yandex.ru   
Sub-Investigator: Esadulla A Osmanov, Professor, MD         
Sub-Investigator: Alexandr A Sinitsyn         
Sub-Investigator: Andrey V Pelevin         
Sub-Investigator: Oksana I Efremova, PhD         
Sub-Investigator: Vladimir E Denisov, PhD         
Sub-Investigator: Natalia U Kondratiuk         
Sponsors and Collaborators
Derzhavin Tambov State University
Investigators
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Principal Investigator: Oksana Bukina, PhD Derzhavin Tambov State University

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

Publications of Results:
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Responsible Party: Oksana Bukina, Director, Clinical Research, Derzhavin Tambov State University
ClinicalTrials.gov Identifier: NCT04132323    
Other Study ID Numbers: A001203
First Posted: October 18, 2019    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The study data are available to all investigators in the chronic vein disease registry.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: From 25 October 2019 to 25 December 2021
URL: https://www.venousregistry.org/index.php?u=1

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Oksana Bukina, Derzhavin Tambov State University:
sclerotherapy, hypertonic glucose, sodium tetradecyl sulfate
Additional relevant MeSH terms:
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Telangiectasis
Vascular Diseases
Cardiovascular Diseases
Sodium Tetradecyl Sulfate
Sclerosing Solutions
Pharmaceutical Solutions