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Laser Cryosclerotherapy versus Conventional Sclerotherapy for Reticular Veins and Telangiectasias: A Randomized
Marcos Fonseca1, Lara Poltronieri2, Rodrigo Argenta2
1Postgraduate Program in Surgery, Ribeirão Preto Medical School, University of São Paulo (USP), Ribeirão Preto, Brazil; Prime Vascular Clinic, Division of Vascular Surgery and Phlebology, Porto Alegre, Rio Grande do Sul, Brazil.
Objective:
To evaluate whether the hybrid Laser Cryosclerotherapy protocol (LCS: Nd:YAG 1064 nm + 75% hypertonic glucose) produces superior aesthetic outcomes compared with combined conventional sclerotherapy (CS: 67.5% glucose + 0.3% polidocanol) for the treatment of lower limb reticular veins and telangiectasias (CEAP C1).
Methods:
Single-center, prospective Randomized Clinical Trial. Sixty patients were assessed for eligibility; four did not provide informed consent and were not randomized. Fifty-six female patients with CEAP C1 disease and Fitzpatrick phototypes I-III were randomized, with only one lower limb treated per participant: 32 to the LCS group (Nd:YAG 1064 nm + HG75%) and 24 to the CS group (HG67.5% + POL0.3%). Two LCS participants were subsequently lost to follow-up between Day 1 and Day 30; 54 participants (30 LCS, 24 CS) completed the 90-day follow-up and were analyzed per protocol. Standardized photographs were obtained at Day 1, Day 30, and Day 90, with and without augmented reality (VeinViewer Flex®), and assessed by two blinded external vascular physicians using the Global Aesthetic Improvement Scale (GAIS). Complications, residual pigmentation, and quality of life (AVVQ) were evaluated as secondary endpoints.
Results:
Both groups had equivalent baseline characteristics. LCS group was superior to CS group in all GAIS outcomes: D1→D90 without AR (p = 0.026; r = 0.34; 95% CI 0.04-0.58; moderate effect); D1→D90 with AR (p < 0.001; r = 0.53; 95% CI 0.28-0.72; large effect); D30→D90 without AR (p < 0.001; r = 0.56; 95% CI 0.31-0.74; large effect); D30→D90 with AR (p < 0.001; r = 0.52; 95% CI 0.26-0.71; large effect). After Bonferroni correction for these four primary comparisons (α = 0.0125), the D1→D90 comparison without AR no longer reached significance, while the remaining three comparisons did. Temporal analysis revealed a progressive late aesthetic response in the LCS group: 80.0% of participants continued improving between Day 30 and Day 90, versus 29.1% in the CS group (70.8% with no change). Ecchymosis duration was significantly shorter in the LCS group (median 5.0 vs 10.0 days; p = 0.012). Severe pigmentation at Day 90 was observed exclusively in the CS group (8.3% vs 0%; p = 0.019; r = 0.22; small effect; power 36.4%; this finding is exploratory, see Discussion). No cases of DVT or ulcer occurred. AVVQ improvement was significant in both groups (p < 0.001), with no intergroup difference. Inter-rater agreement was substantial to near perfect for GAIS (κ = 0.735-0.913) and perfect for complications (κ = 1.000).
Conclusion:
Laser Cryosclerotherapy protocol was superior to CS in all GAIS outcomes, with moderate-to-large effect sizes and consistent inter-rater agreement. Aesthetic response is progressive, consolidating between Day 30 and Day 90, with the largest effect size in the late period. Augmented reality amplified the magnitude of detected effects and improved inter-rater agreement, reinforcing its role as a standardizing tool in aesthetic phlebology RCTs. These statistical findings should be weighed against the greater cost and complexity of LCS relative to conventional sclerotherapy in a purely cosmetic CEAP C1 population (see Discussion).
