Clinical trial NCT04132323: 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
Overall status: COMPLETED
Phase: NA
Conditions: Sclerotherapy
Keywords: sclerotherapy, hypertonic glucose, sodium tetradecyl sulfate
Lead sponsor: Derzhavin Tambov State University
Sponsor class: OTHER
First posted: 2019-10-18
Enrollment: 172
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Disappearance of the telangiectasia
timeFrame: 2 months
Secondary outcomes:
measure: Pain during the procedure: visual analog scale
timeFrame: immediately after the procedure
measure: Patient Satisfaction After Treatment
timeFrame: 2 months
Other outcomes:
Locations:
city: Tambov
country: Russian Federation
facility: Bukina Oksana Vasilyevna
Study officials:
affiliation: Derzhavin Tambov State University
name: Oksana Bukina, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.