Low Concentrate Detergents Versus Hypertonic Glucose for the Treatment of Telangiectasia

NCT ID: NCT04132323

Last Updated: 2023-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-25

Study Completion Date

2022-03-15

Brief Summary

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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

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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.

Conditions

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Sclerotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Sclerotherapy

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

Sclerotherapy

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

Sclerotherapy

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

Sclerotherapy

Intervention Type PROCEDURE

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

Interventions

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Sclerotherapy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Derzhavin Tambov State University

OTHER

Sponsor Role lead

Responsible Party

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Oksana Bukina

Director, Clinical Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oksana Bukina, PhD

Role: PRINCIPAL_INVESTIGATOR

Derzhavin Tambov State University

Locations

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Bukina Oksana Vasilyevna

Tambov, , Russia

Site Status

Countries

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Russia

References

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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.

Reference Type RESULT
PMID: 27738241 (View on PubMed)

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.

Reference Type RESULT
PMID: 20483861 (View on PubMed)

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.

Reference Type RESULT
PMID: 25069999 (View on PubMed)

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.

Reference Type RESULT
PMID: 22221551 (View on PubMed)

Bukina 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.

Reference Type DERIVED
PMID: 37519033 (View on PubMed)

Study Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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A001203

Identifier Type: -

Identifier Source: org_study_id

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