Nd:YAG Laser Combined With Injection Sclerotherapy Versus Diode Laser in the Treatment of Reticular Veins and Telangiectasias Using CLaCS Technique

Comparative Study Between Nd:YAG Laser Combined With Injection Sclerotherapy Versus Diode Laser in the Treatment of Reticular Veins and Telangiectasias Using CLaCS Technique

This study aims to compare the efficacy (in terms of vein clearance) and safety of Nd:YAG laser combined with injection sclerotherapy versus diode laser combined with injection sclerotherapy in the treatment of reticular veins and telangiectasias using the Cryo-Laser and Cryo-Sclerotherapy (CLaCS) technique.

Study Overview

• Status: Recruiting
• Conditions: Telangiectasias; Sclerotherapy; Reticular Veins; Nd:YAG Laser; Diode Laser; CLaCS Technique
• Intervention / Treatment: Device: Nd:YAG laser; Drug: Diode laser

Detailed Description

Reticular veins and telangiectasias (spider veins) represent common chronic venous disorders affecting a large proportion of the adult population, particularly women.

The Cryo-Laser and Cryo-Sclerotherapy (CLaCS) technique has emerged as an innovative method combining transdermal laser therapy, injection sclerotherapy, and skin cooling. This multimodal approach enhances visualization of feeder veins using augmented reality or vein illumination systems, allowing precise targeting and improved clearance rates. Cooling reduces pain and protects the epidermis, making the procedure more tolerable and safer.

Nd:YAG laser (1064 nm) is considered the cornerstone of the CLaCS technique due to its deeper penetration and selective photothermolysis of hemoglobin. It effectively targets deeper reticular veins (up to 3-4 mm depth), induces vessel wall contraction, and facilitates subsequent sclerotherapy.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed A Hagag, MD; Phone Number: 00201126560324; Email: hagagmohamed@med.asu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11591
    • Recruiting
    • Ain Shams University
    • Contact: Mohamed A Hagag, MD; Phone Number: 00201126560324; Email: hagagmohamed@med.asu.edu.eg
    • Principal Investigator: Ahmed G Abdellattif, MD
    • Principal Investigator: Mina G Basta, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged 18-60 years.
• Both sexes.
• Presence of reticular veins and/or telangiectasias (CEAP classification C1).
• Fitzpatrick skin types II-V.
• Patients seeking cosmetic treatment.

Exclusion Criteria:

• Pregnancy or lactation.
• History of deep vein thrombosis.
• Coagulation disorders.
• Allergy to sclerosant agents.
• Active skin infection at treatment site.
• Previous treatment of target veins within 6 months.
• Great saphenous vein or short saphenous vein incompetence.
• Deep venous insufficiency or thrombosis.
• Abnormal venous duplex findings.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A (Nd:YAG Group): Patients will receive Nd:YAG laser (1064 nm) + injection sclerotherapy (CLaCS).	Device: Nd:YAG laser; Patients will receive Nd:YAG laser (1064 nm) + injection sclerotherapy (CLaCS).
Experimental: Group B (Diode Group); Patients will receive Diode laser (980 nm) + injection sclerotherapy (CLaCS).	Drug: Diode laser; Patients will receive Diode laser (980 nm) + injection sclerotherapy (CLaCS).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of vein clearance	Degree of vein clearance will be assessed by immediate endpoint response during laser application, defined as either instantaneous disappearance of the vein or an immediate change in vein color.	6 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of patient satisfaction	Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied).	6 months postoperatively
Degree of pain	Each patient will be instructed about postoperative pain assessment with VAS. VAS (0 represents "no pain" while 10 represents "the worst pain imaginable").	6 months postoperatively
Incidence of complications	Incidence of complications such as hyperpigmentation, burns, and matting will be recorded.	6 months postoperatively
Number of treatment sessions required	Number of treatment sessions required will be recorded.	6 months postoperatively
Recurrence rate	Recurrence rate will be recorded.	6 months postoperatively

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 25, 2026
• First Submitted That Met QC Criteria: June 25, 2026
• First Posted (Actual): July 1, 2026

Study Record Updates

• Last Update Posted (Actual): July 1, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Telangiectasis; Equipment and Supplies; Lasers; Optical Devices; Radiation Equipment and Supplies; Lasers, Semiconductor
• Other Study ID Numbers: IRB 00006379 (17/05/2026)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No