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

NCT07073742 | Not Yet Recruiting Phase 2

• 1 other identifier: 111111
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Varicose Veins of Lower Limb; Spider Veins; Reticular Leg Veins

Keywords

Telangiectasia; CryoLaser and CryoSclerotherapy; Cosmetic phlebology; AI prediction

Outcome Measures

Primary Outcomes (1)

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

  8 weeks

Study Arms (2)

CLaCS with 70% Glucose (Control Group)

ACTIVE COMPARATOR

Participants in this group will undergo the CLaCS procedure using Nd:YAG 1064 nm laser followed by intravascular injection of 70% glucose as the sclerosant. This represents the standard CLaCS protocol and serves as the control arm.

Procedure: CLaCS

CLaCS with 0.2% Polidocanol Foam (Aetoxysklerol) - Test Group

ACTIVE COMPARATOR

Participants in this group will receive the same laser treatment (Nd:YAG 1064 nm) as the control group, but the sclerosant will be a 0.2% polidocanol foam, prepared using the VARIXIO system. This arm evaluates the efficacy of a low-concentration detergent-based alternative.

Procedure: CLaCS

Interventions

CLaCS PROCEDURE

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).

CLaCS with 0.2% Polidocanol Foam (Aetoxysklerol) - Test Group; CLaCS with 70% Glucose (Control Group)

Eligibility Criteria

• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Reflux in trunk veins or perforators.
• Active skin infection at the treatment site.
• Presence of reticular veins.
• Previous sclerotherapy/CLaCS in the target area.

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Related Publications (3)

• Bertanha M, Yoshida WB, Bueno de Camargo PA, Moura R, Reis de Paula D, Padovani CR, Sobreira ML. Polidocanol Plus Glucose Versus Glucose Alone for the Treatment of Telangiectasias: Triple Blind, Randomised Controlled Trial (PG3T). Eur J Vasc Endovasc Surg. 2021 Jan;61(1):128-135. doi: 10.1016/j.ejvs.2020.07.007. Epub 2020 Aug 7.

  PMID: 32778489 RESULT

• Miyake RK, Chi YW, Franklin IJ, Gianesini S. State of the art on cryo-laser cryo-sclerotherapy in lower limb venous aesthetic treatment. J Vasc Surg Venous Lymphat Disord. 2020 Sep;8(5):893-895. doi: 10.1016/j.jvsv.2020.01.003. Epub 2020 Mar 14.

  PMID: 32179040 RESULT

• Gonzalez Ochoa AJ, Carrillo J, Manriquez D, Manrique F, Vazquez AN. Reducing hyperpigmentation after sclerotherapy: A randomized clinical trial. J Vasc Surg Venous Lymphat Disord. 2021 Jan;9(1):154-162. doi: 10.1016/j.jvsv.2020.06.019. Epub 2020 Jul 30.

  PMID: 32739509 RESULT

MeSH Terms

Conditions

Telangiectasis

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Peter Balaz, professor

CONTACT

+420776882216; balazp@fnkv.cz

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 18, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share