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Low Concentrate Detergents Versus Hypertonic Glucose for the Treatment of Telangiectasia

Primary Purpose

Sclerotherapy

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Sclerotherapy
Sponsored by
Derzhavin Tambov State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sclerotherapy focused on measuring sclerotherapy, hypertonic glucose, sodium tetradecyl sulfate

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Bukina Oksana Vasilyevna

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

hypertonic glucose

0.05% sodium tetradecyl sulfate

0.1% sodium tetradecyl sulfate

0.15% sodium tetradecyl sulfate

Arm 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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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)

Full Information

First Posted
October 16, 2019
Last Updated
October 7, 2023
Sponsor
Derzhavin Tambov State University
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1. Study Identification

Unique Protocol Identification Number
NCT04132323
Brief Title
Low Concentrate Detergents Versus Hypertonic Glucose for the Treatment of Telangiectasia
Official Title
Clinical Efficacy of Low Concentrate Detergents Versus Hypertonic Glucose for the Treatment of Telangiectasia: a Prospective Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 25, 2019 (Actual)
Primary Completion Date
March 15, 2022 (Actual)
Study Completion Date
March 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Derzhavin Tambov State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sclerotherapy
Keywords
sclerotherapy, hypertonic glucose, sodium tetradecyl sulfate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
172 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hypertonic glucose
Arm Type
Active Comparator
Arm 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.
Arm Title
0.05% sodium tetradecyl sulfate
Arm Type
Active Comparator
Arm 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.
Arm Title
0.1% sodium tetradecyl sulfate
Arm Type
Active Comparator
Arm 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.
Arm Title
0.15% sodium tetradecyl sulfate
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Sclerotherapy
Intervention Description
Examination, photographing, inclusion in the study, signing of informed consent, randomization, diameter measurement, sclerotherapy according to the randomization group
Primary Outcome Measure Information:
Title
Disappearance of the telangiectasia
Description
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.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Pain during the procedure: visual analog scale
Description
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).
Time Frame
immediately after the procedure
Title
Patient Satisfaction After Treatment
Description
Assessment of patient satisfaction on the 3-point scale : no result (0 points), incomplete satisfaction (1 point), complete satisfaction (2 points)
Time Frame
2 months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oksana Bukina, PhD
Organizational Affiliation
Derzhavin Tambov State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bukina Oksana Vasilyevna
City
Tambov
ZIP/Postal Code
392014
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.venousregistry.org/index.php?u=1
Citations:
PubMed Identifier
27738241
Citation
Bush R, Bush P. Evaluation of sodium tetradecyl sulfate and polidocanol as sclerosants for leg telangiectasia based on histological evaluation with clinical correlation. Phlebology. 2017 Aug;32(7):496-500. doi: 10.1177/0268355516673768. Epub 2016 Oct 12.
Results Reference
result
PubMed Identifier
20483861
Citation
Rabe E, Schliephake D, Otto J, Breu FX, Pannier F. Sclerotherapy of telangiectases and reticular veins: a double-blind, randomized, comparative clinical trial of polidocanol, sodium tetradecyl sulphate and isotonic saline (EASI study). Phlebology. 2010 Jun;25(3):124-31. doi: 10.1258/phleb.2009.009043.
Results Reference
result
PubMed Identifier
25069999
Citation
Parlar B, Blazek C, Cazzaniga S, Naldi L, Kloetgen HW, Borradori L, Buettiker U. Treatment of lower extremity telangiectasias in women by foam sclerotherapy vs. Nd:YAG laser: a prospective, comparative, randomized, open-label trial. J Eur Acad Dermatol Venereol. 2015 Mar;29(3):549-54. doi: 10.1111/jdv.12627. Epub 2014 Jul 28.
Results Reference
result
PubMed Identifier
22221551
Citation
Munia MA, Wolosker N, Munia CG, Chao WS, Puech-Leao P. Comparison of laser versus sclerotherapy in the treatment of lower extremity telangiectases: a prospective study. Dermatol Surg. 2012 Apr;38(4):635-9. doi: 10.1111/j.1524-4725.2011.02226.x. Epub 2011 Dec 30.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.venousregistry.org/index.php?f=1&id=97

Learn more about this trial

Low Concentrate Detergents Versus Hypertonic Glucose for the Treatment of Telangiectasia

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