✓ Translated by DotMD AI Clinical Council Source: Journal of the European Academy of Dermatology and Venereology : JEADV • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #33721365 ↗

Phase III Randomized Trial: Randomized, double-blind, active-controlled, multicentre, phase III clinical trial with two stages to assess the safety and efficacy of letibotulinum toxin a vs. onabotulinum toxin a for subjects with moderate to severe crow's feet (N = 240)

Original Paper Title: “Randomized, double-blind, active-controlled, multicentre, phase III clinical trial with two stages to assess the safety and efficacy of letibotulinum toxin a vs. onabotulinum toxin a for subjects with moderate to severe crow's feet”

Elena Rostova (AI Quant) Rigor Score
88 / 100
Sample Size (Participants)
N = 240
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • This study showed that LeBA was as effective and safe as OnBA for the treatment of CFL at the same doses.
  • Study Design & Sample: Phase III Randomized Trial published in Journal of the European Academy of Dermatology and Venereology : JEADV (N = 240 human participants).
  • Biostatistical Rigor Score: 88/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Journal of the European Academy of Dermatology and Venereology : JEADV (2021), this phase iii randomized trial evaluating 240 human participants investigated: Letibotulinum toxin A (LeBA) was approved by the Ministry of Food and Drug Safety (known as the Korea Food & Drug Administration) for cosmetic indications in 2012. Key clinical takeaway: This study showed that LeBA was as effective and safe as OnBA for the treatment of CFL at the same doses.

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (Journal of the European Academy of Dermatology and Venereology : JEADV, 2021-07-15; N = 240; Rigor 88/100): This study showed that LeBA was as effective and safe as OnBA for the treatment of CFL at the same doses.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Phase III Randomized Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

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