Rodrigues Anelise, Puggina Juliana, da Silva Viviane Santana, Ribeiro Camilla Moreira, Santiago Fabrício Rodrigues, Neves Samantha, Simoni Gabriel Henrique, Portugal Maria Fernanda, Ramacciotti Eduardo
Clínica Dra. Anelise Rodrigues, Cuiabá, MT, Brazil; Vascular Surgery, Irmandade da Santa Casa de Misericórdia de São Paulo, São Paulo, SP, Brazil.
Instituto Circular, São Paulo, SP, Brazil.
J Vasc Surg Venous Lymphat Disord. 2025 Jul 11;13(6):102285. doi: 10.1016/j.jvsv.2025.102285.
Skin hyperpigmentation is a common complication after leg vein sclerotherapy and a primary concern for patients with cosmetic complaints. The aim of this study was to determine if cryo-laser cryo-sclerotherapy technique (CLaCS) presents a lower incidence and intensity pigmentation after procedure compared with 0.5% polidocanol foam sclerotherapy, 60 days after a single treatment of reticular veins.
This was an open-label, prospective, within-patient, randomized, active controlled, safety trial with blind evaluators. Interventions took place from August through September 2021, with a 2-month follow-up. Interventions were performed in a private clinic. Eligible patients were volunteers over 18 years old, with aesthetic discomfort related to bilateral lower limb reticular veins, similar length and distribution, with veins' internal diameter up to 2.2 mm in B-mode ultrasound. Patients underwent consecutive CLaCS treatment in one limb and 0.5% polidocanol foam in the contralateral limb on the same day. The primary outcome was the presence of post-procedure pigmentation in treated areas 60 days after a single treatment, determined through photo evaluation and objective measurement of skin color dissimilarity between the treated area and the adjacent skin, using a precision colorimeter. Patients' aesthetic satisfaction improvement, vein diameter reduction, and minor/major adverse events were also assessed.
Twenty-three women (46 limbs) were treated, and two were lost to follow-up. No significant statistical difference in the number of limbs that developed posttreatment pigmentation was found for both photo (7 CLaCS vs 5 foam; P = .8906) and colorimetric (9 CLaCS vs 13 foam; P = .1445) evaluations. The CLaCS group had significantly lower intensity of pigmentation in colorimetry (mean ΔE of 1.30 for CLaCS vs 1.44 for foam; P = .02735). No significant difference in veins' diameter reduction was found. Both groups presented substantial improvement in patients' satisfaction with their leg appearance.
Although no statistical difference was found regarding the number of limbs that developed hypercromia after treatment of the reticular veins, CLaCS resulted in a lower intensity of skin color dissimilarity, less microthrombi formation and drainage, less bruising and lower volume of sclerosant needed, without difference in diameter reduction rates, compared with polidocanol foam sclerotherapy. No major adverse events were reported.
皮肤色素沉着是腿部静脉硬化治疗后的常见并发症，也是有美容诉求患者的主要担忧。本研究的目的是确定与0.5%聚多卡醇泡沫硬化疗法相比，冷冻激光冷冻硬化疗法（CLaCS）在单次治疗网状静脉60天后，术后色素沉着的发生率和严重程度是否更低。
这是一项开放标签、前瞻性、患者内随机、活性对照、安全性试验，评估者为盲法。干预措施于2021年8月至9月进行，随访2个月。干预在一家私人诊所进行。符合条件的患者为18岁以上志愿者，因双侧下肢网状静脉存在美学不适，静脉长度和分布相似，B超显示静脉内径达2.2mm。患者在同一天，一侧肢体接受连续CLaCS治疗，对侧肢体接受0.5%聚多卡醇泡沫治疗。主要结局是单次治疗60天后治疗区域术后色素沉着情况，通过照片评估以及使用精密色度计客观测量治疗区域与相邻皮肤之间的肤色差异来确定。还评估了患者的美学满意度改善情况、静脉直径缩小情况以及轻微/严重不良事件。
23名女性（46条肢体）接受了治疗，2名失访。在照片评估（7条CLaCS治疗肢体 vs 5条泡沫治疗肢体；P = 0.8906）和比色法评估（9条CLaCS治疗肢体 vs 13条泡沫治疗肢体；P = 0.1445）中，治疗后出现色素沉着的肢体数量均未发现显著统计学差异。CLaCS组在比色法中色素沉着严重程度显著更低（CLaCS组平均ΔE为1.30，泡沫治疗组为1.44；P = 0.02735）。静脉直径缩小方面未发现显著差异。两组患者对腿部外观的满意度均有显著改善。
虽然在网状静脉治疗后出现色素沉着的肢体数量方面未发现统计学差异，但与聚多卡醇泡沫硬化疗法相比，CLaCS导致的肤色差异强度更低、微血栓形成和引流更少、瘀斑更少且所需硬化剂体积更小，静脉直径缩小率无差异。未报告严重不良事件。
