BOTOX® for the Treatment of Platysma Prominence

Summary

To assess the efficacy and safety of BOTOX® in adults with moderate to severe platysma prominence.

Timeline

Start

2019-04-23

Primary completion

2020-04-16

Completion

2020-04-16

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs BOTOX® Low Dose; p <0.0001; Rate Difference 65.8 (95% CI 51.5 to 80.1); NCT03915067 ↗

registry analysis (superiority test); Placebo vs BOTOX® High Dose; p <0.0001; Rate Difference 76.2 (95% CI 63.6 to 88.9); NCT03915067 ↗

paper The primary end point was met for both onabotulinumtoxinA groups PMID 38640068 ↗

Publications

• Humphrey S, Shimoga S, Kaufman J, Bank D, Biesman B, Harutunian C, West GS, Tong W, Patel V. Patient-Reported Outcomes After Treatment With OnabotulinumtoxinA for Platysma Prominence: Results From a Phase 2 Dose-Ranging Study. J Cosmet Dermatol. 2026 Apr;25(4):e70821. doi: 10.1111/jocd.70821.
• Garcia JK, Hopfinger RM, Foley C, Whyte J, Gauthier M, Foster B, Patel V. Development and validation of patient-reported outcome measures for platysma prominence. Curr Med Res Opin. 2025 Jul;41(7):1277-1290. doi: 10.1080/03007995.2025.2537898. Epub 2025 Jul 31.
• Rohrich RJ, Bertucci V, Dayan S, Jones D, Solish N, Rivers JK, Weiss RA, Muhn CY, Harutunian C, Park GS, Shimoga S, Lee E, Tong W. Efficacy and Safety of OnabotulinumtoxinA for the Treatment of Platysma Prominence: A Randomized Phase 2 Dose-Ranging Study. Plast Reconstr Surg. 2025 Jan 1;155(1):79-88. doi: 10.1097/PRS.0000000000011472. Epub 2024 Apr 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Botulinum toxin type A	Protein / enzyme biologic	26 iu	Intramuscular
Subject	Botulinum toxin type A	Protein / enzyme biologic	31 iu	Intramuscular
Subject	Botulinum toxin type A	Protein / enzyme biologic	36 iu	Intramuscular
Subject	Botulinum toxin type A	Protein / enzyme biologic	52 iu	Intramuscular
Subject	Botulinum toxin type A	Protein / enzyme biologic	62 iu	Intramuscular
Subject	Botulinum toxin type A	Protein / enzyme biologic	72 iu	Intramuscular

Indications

No indication recorded.