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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • CLaCS

    Procedure/Surgery

    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).

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: CLaCS with 70% Glucose (Control Group)Active comparator 1 intervention
Group B: CLaCS with 0.2% Polidocanol Foam (Aetoxysklerol) - Test GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

To assess the rate of telangiectasia elimination using CLaCS with two types of sclerosants (G-70 and AET-0.2).

Time frame
8 weeks

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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