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Randomised controlled clinical trial to evaluate the efficacy of a sodium salicylate hydroglyceric solution used at different concentrations in the aesthetic and functional sclerotherapy of veins, venulae and ecstatic capillaries. - ND

Randomised controlled clinical trial to evaluate the efficacy of a sodium salicylate hydroglyceric solution used at different concentrations in the aesthetic and functional sclerotherapy of veins, venulae and ecstatic capillaries. - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-005147-10-IT
Enrollment
60
Registered
2006-11-27
Start date
2005-01-31
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with ecstatic vessels in inferior limbs MedDRA version: 6.1 Level: HLGT Classification code 10057165

Interventions

Product Name: Bisclero Pharmaceutical Form: Solution for infusion CAS Number: 54-21-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 180- Pharmaceutical form of th

Sponsors

KORPO S.R.L.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Male and female patients aged between 18 and 75 years, fair phototype, with injuries at inferior limbs, diameter of the injuries less than 8 mm. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients with a saphenous vein failure; b deep venous obstruction; c varicose veins; d dermathosis; e obesity BMI 30 Kg/m2 ; f individual hypersensitivity to the investigational medicinal product or to one of the eccipients; g serious nervous, cardiovascular, liver, kidney and gastrointestinal diseases; h pregnancy or breastfeeding; i hormones therapy

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the efficacy of a sodium salicylate hydroglyceric solution experimental name Bisclero used at different concentrations 6 and 10 in the aesthetic and functional sclerotherapy of veins, venulae and ecstatic capillaries by comparing the effects with those of a placebo solution of Ringer lactate.;Secondary Objective: To evaluate the tolerability of Bisclero used at different concentrations 6 and 10 in the aesthetic and functional sclerotherapy of veins, venulae and ecstatic capillaries;Primary end point(s): Visual evaluation of ecstatic vessels measured on a visual analogue scale VAS based on 4 criteria; colour, thickness, height and surface of the vassels from 0 maximum seriousness to 10 no injury . Primary endpoint is the difference between baseline and after treatment evaluations.—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026