Low Concentrate Detergents Versus Hypertonic Glucose for the Treatment of Telangiectasia

Sclerotherapy Clinical Trial

Official title:

Clinical Efficacy of Low Concentrate Detergents Versus Hypertonic Glucose for the Treatment of Telangiectasia: a Prospective Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04132323
• Other study ID #: A001203
• Status: Completed
• Phase: N/A
• Start date: October 25, 2019
• Est. completion date: March 15, 2022

Study information

• Verified date: March 2022
• Source: Derzhavin Tambov State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: March 15, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Sclerotherapy
• Telangiectasis

Intervention

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

Locations

Country	Name	City	State
Russian Federation	Bukina Oksana Vasilyevna	Tambov

Sponsors (1)

Lead Sponsor	Collaborator
Derzhavin Tambov State University

Country where clinical trial is conducted

Russian Federation, 

References & Publications (4)

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. — View 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 — View 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 Ve — View 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 Ju — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)	2 months