Journal of vascular surgery. Venous and lymphatic disorders · 2025
Pigmentation after foam or cryo-laser cryo-sclerotherapy for lower limb reticular veins: A within-patient randomized trial.
СтатьяРандомизированное исследованиеСравнительное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Rodrigues Anelise, Puggina Juliana, da Silva Viviane Santana, Ribeiro Camilla Moreira, Santiago Fabrício Rodrigues, Neves Samantha, Simoni Gabriel Henrique, Portugal Maria Fernanda, Ramacciotti Eduardo
Аннотация
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.