CLaCS Technique, Diode Laser, Nd:YAG Laser, Reticular Veins, Sclerotherapy, Telangiectasias
Conditions
Brief summary
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.
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.
Interventions
DEVICENd:YAG laser
Patients will receive Nd:YAG laser (1064 nm) + injection sclerotherapy (CLaCS).
DRUGDiode laser
Patients will receive Diode laser (980 nm) + injection sclerotherapy (CLaCS).
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of vein clearance | 6 months postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Degree of pain | 6 months postoperatively | Each patient will be instructed about postoperative pain assessment with VAS. VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). |
| Degree of patient satisfaction | 6 months postoperatively | 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). |
| Incidence of complications | 6 months postoperatively | Incidence of complications such as hyperpigmentation, burns, and matting will be recorded. |
| Number of treatment sessions required | 6 months postoperatively | Number of treatment sessions required will be recorded. |
| Recurrence rate | 6 months postoperatively | Recurrence rate will be recorded. |
Countries
Egypt
Contacts
CONTACTMohamed A Hagag, MD
Outcome results
None listed