INTRODUCTION: A new U.S. Botulinum toxin type A (BoNT-A) has been shown to be safe and effective when administered once, but there is a paucity of clinical evidence regarding long-term use. OBJECTIVE: To evaluate the long-term efficacy and tolerability of repeated treatment with BoNT-A in the correction of moderate-to-severe glabellar lines. STUDY DESIGN/ METHODOLOGY: Multicenter, phase 3, randomized, placebo-controlled, double-blind study comparing the efficacy of BoNT-A (50 units) with placebo upon re-treatment of glabellar lines following two-to-three cycles of open-label BoNT-A treatment in 311 patients. RESULTS: At endpoint, BoNT-A produced a significantly higher proportion of responders versus placebo. The incidence of treatment-emergent adverse effects (TEAEs) was slightly lower during additional treatment cycles; the frequency was comparable between BoNT-A and placebo groups. CONCLUSION: Multiple treatment cycles of BoNT-A were well tolerated in the majority of patients, and there was no tachyphylaxis seen during the study duration of up to 23 months.
RCT Entities:
INTRODUCTION: A new U.S. Botulinum toxin type A (BoNT-A) has been shown to be safe and effective when administered once, but there is a paucity of clinical evidence regarding long-term use. OBJECTIVE: To evaluate the long-term efficacy and tolerability of repeated treatment with BoNT-A in the correction of moderate-to-severe glabellar lines. STUDY DESIGN/ METHODOLOGY: Multicenter, phase 3, randomized, placebo-controlled, double-blind study comparing the efficacy of BoNT-A (50 units) with placebo upon re-treatment of glabellar lines following two-to-three cycles of open-label BoNT-A treatment in 311 patients. RESULTS: At endpoint, BoNT-A produced a significantly higher proportion of responders versus placebo. The incidence of treatment-emergent adverse effects (TEAEs) was slightly lower during additional treatment cycles; the frequency was comparable between BoNT-A and placebo groups. CONCLUSION: Multiple treatment cycles of BoNT-A were well tolerated in the majority of patients, and there was no tachyphylaxis seen during the study duration of up to 23 months.
Authors: Mark Nestor; Joel L Cohen; Marina Landau; Said Hilton; Andreas Nikolis; Syed Haq; Maurizio Viel; Bill Andriopoulos; Inna Prygova; Keith Foster; Alessio Redaelli; Philippe Picaut Journal: J Clin Aesthet Dermatol Date: 2020-12-01
Authors: Cristina Pires Camargo; Jun Xia; Caroline S Costa; Rolf Gemperli; Maria Dc Tatini; Max K Bulsara; Rachel Riera Journal: Cochrane Database Syst Rev Date: 2021-07-05