Low Concentrate Detergents Versus Hypertonic Glucose for the Treatment of Telangiectasia
Clinical Efficacy of Low Concentrate Detergents Versus Hypertonic Glucose for the Treatment of Telangiectasia: a Prospective Randomized Clinical Trial
1 other identifier
interventional
172
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2019
CompletedFirst Posted
Study publicly available on registry
October 18, 2019
CompletedStudy Start
First participant enrolled
October 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2022
CompletedOctober 10, 2023
March 1, 2022
2.4 years
October 16, 2019
October 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
2 months
Secondary Outcomes (2)
Pain during the procedure: visual analog scale
immediately after the procedure
Patient Satisfaction After Treatment
2 months
Study Arms (4)
hypertonic glucose
ACTIVE COMPARATOR* 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.
0.05% sodium tetradecyl sulfate
ACTIVE COMPARATOR* 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.
0.1% sodium tetradecyl sulfate
ACTIVE COMPARATOR* 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.
0.15% sodium tetradecyl sulfate
ACTIVE COMPARATOR* 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.
Interventions
Examination, photographing, inclusion in the study, signing of informed consent, randomization, diameter measurement, sclerotherapy according to the randomization group
Eligibility Criteria
You may qualify if:
- women over 18
- single primary or secondary telangiectasias unrelated to the reticular veins
- signed informed consent to participate in the study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bukina Oksana Vasilyevna
Tambov, 392014, Russia
Related Publications (5)
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.
PMID: 27738241RESULTRabe 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.
PMID: 20483861RESULTParlar 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.
PMID: 25069999RESULTMunia 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.
PMID: 22221551RESULTBukina OV, Sinitsyn AA, Efremova OI, Pelevin AV. Low concentration of sodium tetradecyl sulfate and hypertonic glucose solution for the treatment of telangiectasia: A prospective randomized clinical trial. Phlebology. 2023 Oct;38(9):622-627. doi: 10.1177/02683555231191969. Epub 2023 Jul 30.
PMID: 37519033DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oksana Bukina, PhD
Derzhavin Tambov State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Clinical Research
Study Record Dates
First Submitted
October 16, 2019
First Posted
October 18, 2019
Study Start
October 25, 2019
Primary Completion
March 15, 2022
Study Completion
March 15, 2022
Last Updated
October 10, 2023
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- From 25 October 2019 to 25 December 2021
The study data are available to all investigators in the chronic vein disease registry.