Dermatology Research Institute, LLC, Coral Gables, Florida, USA.
Dermatol Surg. 2010 Dec;36 Suppl 4:2111-8. doi: 10.1111/j.1524-4725.2010.01711.x.
Botulinum toxin type A (BoNTA) is commonly injected to treat facial wrinkles. Complications include pain, erythema, bruising, and potential infection. RT001 Botulinum Toxin Type A Topical Gel (RT001) is under development for the treatment of lateral canthal lines (LCLs).
To assess the efficacy and safety of RT001 for the treatment of LCLs using a randomized, double-blind, repeat-dose, placebo-controlled study design.
METHODS & MATERIALS: Healthy adult subjects were randomized to receive RT001 (N=19) or placebo (N=17) applied to their lateral canthal areas (LCAs). To evaluate safety of repeat exposure, treatment was administered at baseline and week 4. The primary efficacy measure was improvement in baseline LCL severity using the Investigator's Global Assessment of Lateral Canthal Line at Rest (IGA-LCL) Severity Scale.
At 8 weeks, 19 (50%) LCAs treated with RT001 showed a 2-point or greater improvement in baseline IGA-LCL severity, versus none (0%) of the placebo-treated subjects (p<.001); 36 (94.7%) LCAs treated with RT001 showed a 1-point or more improvement in baseline IGA-LCL severity, versus five (14.7%) placebo-treated LCAs (p<.001). There were no treatment-related adverse events.
RT001 was well tolerated and demonstrated an improvement in LCLs.
肉毒毒素 A 型（BoNTA）常用于治疗面部皱纹。其并发症包括疼痛、红斑、瘀伤和潜在感染。RT001 肉毒毒素 A 局部凝胶（RT001）正在开发用于治疗外侧眶纹（LCL）。
采用随机、双盲、重复剂量、安慰剂对照研究设计，评估 RT001 治疗 LCL 的疗效和安全性。
健康成年受试者随机接受 RT001（N=19）或安慰剂（N=17）治疗外侧眶区（LCAs）。为了评估重复暴露的安全性，在基线和第 4 周进行治疗。主要疗效指标是使用研究者对静止时外侧眶纹的整体评估（IGA-LCL）严重程度量表评估基线 LCL 严重程度的改善。
8 周时，19 个（50%）接受 RT001 治疗的 LCA 在基线 IGA-LCL 严重程度上改善了 2 个点或更多，而接受安慰剂治疗的受试者无一例（0%）（p<.001）；36 个（94.7%）接受 RT001 治疗的 LCA 在基线 IGA-LCL 严重程度上改善了 1 个点或更多，而接受安慰剂治疗的 5 个（14.7%）LCA（p<.001）。没有与治疗相关的不良事件。
RT001 耐受性良好，可改善 LCL。
