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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hypertonic glucose | Active Comparator |
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| 0.05% sodium tetradecyl sulfate | Active Comparator |
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| 0.1% sodium tetradecyl sulfate | Active Comparator |
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| 0.15% sodium tetradecyl sulfate | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sclerotherapy | Procedure | Examination, photographing, inclusion in the study, signing of informed consent, randomization, diameter measurement, sclerotherapy according to the randomization group |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | immediately after the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oksana Bukina, PhD | Derzhavin Tambov State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bukina Oksana Vasilyevna | Tambov | 392014 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27738241 | Result | 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. | |
| 20483861 | Result | 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. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
The study data are available to all investigators in the chronic vein disease registry.
From 25 October 2019 to 25 December 2021
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| ID | Term |
|---|---|
| D015911 | Sclerotherapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Patient Satisfaction After Treatment | Assessment of patient satisfaction on the 3-point scale :
| 2 months |
| 25069999 | Result | 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. |
| 22221551 | Result | 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. |
| 37519033 | Derived | 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. |