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NOT YET RECRUITING
NCT07073742
PHASE2

CLaCS Using 0.2% Aetoxysklerol Foam and 70% Glucose for the Treatment of Lower Limb Telangiectasias

Sponsor: Charles University, Czech Republic

View on ClinicalTrials.gov

Summary

This randomized, controlled, non-inferiority trial aims to compare the efficacy of two sclerosants used in the CLaCS (CryoLaser and CryoSclerotherapy) method for treating telangiectasias and reticular varicose veins. CLaCS is an advanced outpatient procedure that combines Nd\\:YAG laser treatment with sclerotherapy to enhance vein closure and cosmetic outcomes while minimizing side effects. The trial will compare the standard 70% glucose sclerosant with a novel 0.2% Aetoxysklerol (polidocanol) foam prepared using the VARIXIO system. Despite widespread use of CLaCS, no head-to-head studies currently exist comparing these two agents. This study aims to determine whether low-concentration Aetoxysklerol foam is non-inferior to 70% glucose in achieving effective telangiectasia elimination.

Official title: Randomized, Controlled, Non-Inferiority Trial on the Efficacy of CLaCS Using 0.2% Aetoxysklerol Foam and 70% Glucose for the Treatment of Lower Limb Telangiectasias

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2025-09-01

Completion Date

2028-09-01

Last Updated

2025-07-18

Healthy Volunteers

Yes

Interventions

PROCEDURE

CLaCS

CLaCS is hybrid outpatient procedure combining Nd:YAG 1064 nm laser treatment with injection of a sclerosant (either 70% glucose or 0.2% polidocanol foam).