*Private Clinic, Alvaro Obregon, Mexico, D.F.; †Private Clinic, Colonia Roma, Mexico, D.F.; ‡Revance Therapeutics, Inc., Newark, California.
Dermatol Surg. 2015 Jan;41 Suppl 1:S47-55. doi: 10.1097/DSS.0000000000000276.
RT002 is a new injectable BoNTA product. This formulation limits the spread of BoNTA, potentially permitting safe administration of larger doses and possibly extending its duration of action.
This phase 1/2 clinical study was designed to establish the safety of RT002 for the treatment of moderate-to-severe glabellar lines.
Subjects were randomized into four groups (N=12/group). Cohorts 1-3 received escalating doses of RT002 ranging from half the equivalent dose of approved toxins up to twice the current dose levels. The safety of each dose was confirmed prior to administering the next dose. Subjects in Cohort 4 were treated with the highest dose and observed for 36 weeks or until GLSS returned to baseline.
All doses of RT002 were well-tolerated. Common AEs were headache and mild injection site reactions. At Week 4, all doses of RT002 were highly effective at maximum frown. Cohort 4 achieved 7 month median duration. At 6 months, 80% of subjects maintained a ≥1-point improvement in Investigator GLSS and 60% maintained WSS of None or Mild. Study limitations include an open-label design and modest number of subjects.
RT002 is a safe and effective BoNTA product with an extended duration of action.
RT002 是一种新型的可注射型 BoNTA 产品。这种配方限制了 BoNTA 的扩散，有可能允许安全地给予更大剂量，并可能延长其作用持续时间。
本 1/2 期临床研究旨在确定 RT002 治疗中度至重度皱眉纹的安全性。
受试者随机分为四组（每组 N=12）。队列 1-3 接受递增剂量的 RT002，范围从批准毒素等效剂量的一半到目前剂量水平的两倍。在给予下一剂量之前，确认了每个剂量的安全性。队列 4 的受试者接受了最高剂量的治疗，并观察了 36 周或直到 GLSS 恢复到基线。
所有剂量的 RT002 均耐受良好。常见的不良反应是头痛和轻度注射部位反应。在第 4 周，所有剂量的 RT002 在最大皱眉时均具有高度疗效。队列 4 达到了 7 个月的中位数持续时间。在 6 个月时，80%的受试者在研究者 GLSS 上保持了≥1 点的改善，60%的受试者保持了 WSS 为无或轻度。研究的局限性包括开放性设计和受试者数量较少。
RT002 是一种安全有效的 BoNTA 产品，作用持续时间延长。
