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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorCharles University, Czech Republic

About this trial

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.

Eligibility criteria

Qualifiers

Signed informed consent.

Age > 18 years.

CEAP classification C1 (telangiectasias only).

Treated area for the study must be ≤ 20x20 cm on the lower limb - thigh.

Disqualifiers

Reflux in trunk veins or perforators.

Active skin infection at the treatment site.

Presence of reticular veins.

Previous sclerotherapy/CLaCS in the target area.

Trial design

Treatments tested in this trial

  • CLaCS

Treatment groups

240 Participants
are divided into 2 treatment groups

Locations

This trial has no locations