BACKGROUND:Sixty-three subjects' legs were randomized to receive treatment with polidocanol (POL) or hypertonic saline (HS) for telangiectasias and reticular leg veins. OBJECTIVE: To compare the safety and efficacy of two sclerosing agents in three dermatologic surgery practices. METHODS: After exclusion of saphenofemoral junction incompetence, each subject's veins were categorized (telangiectasias <1 mm and reticular veins 1-3 mm) and randomized. Telangiectasias were treated with POL 0.5% or 11.7% HS and reticular veins with POL 1% or 23.4% HS. An independent, blinded physician determined efficacy and adverse events. Subject satisfaction questionnaires were administered and global clinical improvement assessments performed. RESULTS: All patients completed four visits at 0, 1, 4, and 12 weeks. Patients reported significantly greater pain during treatment with HS (2.42) than POL (1.03) (p < .001). There were no significant differences in physician-assessed improvement of reticular leg veins or telangiectasias; subject- or physician-assessed overall improvement; or physician-assessed phlebitis, pigmentation, edema, or matting in either of the three practices or the entire cohort. Two subjects developed ulcerations with HS. No ulcerations or allergic reactions developed after POL injections. CONCLUSION: Both agents provided effective treatment, but HS caused 2.35 times as much pain during injections and resulted in two episodes of tissue necrosis.
RCT Entities:
BACKGROUND: Sixty-three subjects' legs were randomized to receive treatment with polidocanol (POL) or hypertonic saline (HS) for telangiectasias and reticular leg veins. OBJECTIVE: To compare the safety and efficacy of two sclerosing agents in three dermatologic surgery practices. METHODS: After exclusion of saphenofemoral junction incompetence, each subject's veins were categorized (telangiectasias <1 mm and reticular veins 1-3 mm) and randomized. Telangiectasias were treated with POL 0.5% or 11.7% HS and reticular veins with POL 1% or 23.4% HS. An independent, blinded physician determined efficacy and adverse events. Subject satisfaction questionnaires were administered and global clinical improvement assessments performed. RESULTS: All patients completed four visits at 0, 1, 4, and 12 weeks. Patients reported significantly greater pain during treatment with HS (2.42) than POL (1.03) (p < .001). There were no significant differences in physician-assessed improvement of reticular leg veins or telangiectasias; subject- or physician-assessed overall improvement; or physician-assessed phlebitis, pigmentation, edema, or matting in either of the three practices or the entire cohort. Two subjects developed ulcerations with HS. No ulcerations or allergic reactions developed after POL injections. CONCLUSION: Both agents provided effective treatment, but HS caused 2.35 times as much pain during injections and resulted in two episodes of tissue necrosis.
Authors: Matheus Bertanha; Marcone Lima Sobreira; Carlos Eduardo Pinheiro Lúcio Filho; Jamil Victor de Oliveira Mariúba; Rafael Elias Farres Pimenta; Rodrigo Gibin Jaldin; Andrei Moroz; Regina Moura; Hamilton Almeida Rollo; Winston Bonetti Yoshida Journal: Trials Date: 2014-12-19 Impact factor: 2.279
Authors: E Rabe; F X Breu; I Flessenkämper; H Gerlach; S Guggenbichler; B Kahle; R Murena; S Reich-Schupke; T Schwarz; M Stücker; E Valesky; S Werth; F Pannier Journal: Hautarzt Date: 2021-12 Impact factor: 0.751
Authors: Matheus Bertanha; Paula Angeleli Bueno de Camargo; Regina Moura; Winston Bonetti Yoshida; Rafael Elias Farres Pimenta; Jamil Victor de Oliveira Mariúba; Giovana Piteri Alcantara; Dênia Reis de Paula; Marcone Lima Sobreira Journal: Medicine (Baltimore) Date: 2016-09 Impact factor: 1.889