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Background <p>Botulinum toxin type A injections are widely used for the aesthetic treatment of glabellar lines;&#xa0;however, data on the efficacy and safety of newer formulations remain limited.</p> Aim <p>This systematic review and meta-analysis aims to assess the efficacy and safety of the novel botulinum toxin LetibotulinumtoxinA-wlbg compared to placebo for treating moderate-to-severe glabellar lines.</p> Methods <p>A systematic literature search was conducted to identify randomized controlled trials (RCTs) comparing LetibotulinumtoxinA-wlbg with placebo in adults. A meta-analysis was performed using random-effects models, and the Cochrane RoB-2 tool was used to assess the risk of bias.</p> Results <p>Three RCTs including 1272 patients were analyzed. LetibotulinumtoxinA-wlbg was significantly more effective than placebo for the primary outcome, the composite responder rate at week 4 (risk ratio [RR] = 59.47; 95% CI: 14.95, 236.52). Sustained efficacy was observed at weeks 12 and 16, with significant improvements also seen in investigator-assessed, subject-assessed, and psychological outcomes. The safety analysis revealed no significant increase in the risk of serious, non-serious, or overall treatment-emergent adverse events.</p> Conclusions <p>LetibotulinumtoxinA-wlbg is an efficacious and well-tolerated treatment for moderate-to-severe glabellar lines.&#xa0;The therapeutic effect is durable, with statistically significant efficacy maintained at 12 and 16 weeks post-treatment. Treatment results in a significant improvement in patients’ psychological well-being related to their facial appearance. The safety profile is favorable, with no statistically significant increase in the risk of serious or non-serious adverse events compared to placebo. Further research, including direct head-to-head trials, is warranted to establish its comparative effectiveness.</p> Level of Evidence I <p>This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors <a href="http://www.springer.com/00266">www.springer.com/00266</a>.</p>

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Efficacy and Safety of LetibotulinumtoxinA for the Treatment of Moderate-to-Severe Glabellar Lines: A Systematic Review and Meta-Analysis of RCTs

  • 期刊论文

  • 发表日期：

    2026年1月7日

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  • Musa Masood,
  • Rao Sikandar Shamim Khan,
  • Saad Masood,
  • Umm E. Aimen Minhas,
  • Sayyam Sohail

摘要

Background

Botulinum toxin type A injections are widely used for the aesthetic treatment of glabellar lines; however, data on the efficacy and safety of newer formulations remain limited.

Aim

This systematic review and meta-analysis aims to assess the efficacy and safety of the novel botulinum toxin LetibotulinumtoxinA-wlbg compared to placebo for treating moderate-to-severe glabellar lines.

Methods

A systematic literature search was conducted to identify randomized controlled trials (RCTs) comparing LetibotulinumtoxinA-wlbg with placebo in adults. A meta-analysis was performed using random-effects models, and the Cochrane RoB-2 tool was used to assess the risk of bias.

Results

Three RCTs including 1272 patients were analyzed. LetibotulinumtoxinA-wlbg was significantly more effective than placebo for the primary outcome, the composite responder rate at week 4 (risk ratio [RR] = 59.47; 95% CI: 14.95, 236.52). Sustained efficacy was observed at weeks 12 and 16, with significant improvements also seen in investigator-assessed, subject-assessed, and psychological outcomes. The safety analysis revealed no significant increase in the risk of serious, non-serious, or overall treatment-emergent adverse events.

Conclusions

LetibotulinumtoxinA-wlbg is an efficacious and well-tolerated treatment for moderate-to-severe glabellar lines. The therapeutic effect is durable, with statistically significant efficacy maintained at 12 and 16 weeks post-treatment. Treatment results in a significant improvement in patients’ psychological well-being related to their facial appearance. The safety profile is favorable, with no statistically significant increase in the risk of serious or non-serious adverse events compared to placebo. Further research, including direct head-to-head trials, is warranted to establish its comparative effectiveness.

Level of Evidence I

This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.