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Clinical Trial
. 2026 Apr;25(4):e70821.
doi: 10.1111/jocd.70821.

Patient-Reported Outcomes After Treatment With OnabotulinumtoxinA for Platysma Prominence: Results From a Phase 2 Dose-Ranging Study

Shannon Humphrey  1 , Sandhya Shimoga  2 , Joely Kaufman  3 , David Bank  4 , Brian Biesman  5 , Christy Harutunian  2 , Grace S West  2 , Warren Tong  6 , Vaishali Patel  2
Affiliations
Clinical Trial

Patient-Reported Outcomes After Treatment With OnabotulinumtoxinA for Platysma Prominence: Results From a Phase 2 Dose-Ranging Study

Shannon Humphrey et al. J Cosmet Dermatol. 2026 Apr.

Abstract

Background: Repetitive contractions of the platysma muscle may result in vertical neck bands that blunt the jawline (i.e., platysma prominence [PP]). We report patient-reported outcomes (PROs) from a phase 2 study evaluating onabotulinumtoxinA (onabotA) for moderate or severe PP.

Methods: Subjects were randomized 1:1:1 to onabotA dose 1 (26 U, 31 U, or 36 U), onabotA dose 2 (52 U, 62 U, or 72 U), or placebo. De novo, validated, fit-for-purpose PROs were used to assess treatment satisfaction, bother with vertical neck bands and jawline, jawline definition, and psychosocial impact.

Results: Subjects with PRO data (N = 164; mean age, 50.0 years) were predominantly female (95.1%) and White (93.9%). Response rates for improvement in both onabotA dose groups were higher than placebo for treatment satisfaction, bother with vertical neck bands and jawline, as well as jawline definition (unadjusted p < 0.05 for all). Greater improvements in treatment satisfaction and psychosocial impact were observed in both dose groups versus placebo based on the mean total scores on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Satisfaction and the mean change from baseline in ANLFQ: Impacts total score, respectively (unadjusted p < 0.0001 for all). Response rates generally peaked across all measures at day 14 or 30 for both dose groups, with a trend in improvement continuing through day 120.

Conclusions: Compared with placebo, both onabotA dose groups reported greater satisfaction with the effect of treatment, improvements in jawline definition and psychological impact, as well as reductions in bother due to vertical neck bands and jawline.

Trial registration: ClinicalTrials.gov: NCT03915067.

Keywords: botulinum toxin A; cosmetic techniques; neck; patient satisfaction; skin aging; treatment outcome.

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Conflict of interest statement

Shannon Humphrey is an investigator for Allergan Aesthetics (an AbbVie company). Warren Tong is a full‐time employee of Allergan Aesthetics (an AbbVie company) and current stockholder of AbbVie. Sandhya Shimoga, Grace S. West, and Vaishali Patel are full‐time employees of AbbVie and may own AbbVie stock. Joely Kaufman is an advisory board member for and receives research funding from AbbVie. David Bank has received funding as an investigator, consultant, and trainer for Allergan (an AbbVie company), Croma, Endo, Evolus, Galderma, and Revance. Brian Biesman receives research support from Allergan (an AbbVie company), Galderma, and Merz and is a consultant for Allergan (an AbbVie company), Galderma, Merz, and Revance. Christy Harutunian is a former employee and current stockholder of AbbVie as well as an employee of ASLAN Pharmaceuticals.

Figures

FIGURE 1
FIGURE 1
Injection sites based on baseline Clinician Allergan Platysma Prominence Scale (C‐APPS) score of grade 3 (left) or grade 4 (right). Reprinted with permission from Rohrich et al. [4].
FIGURE 2
FIGURE 2
ANLFQ: Satisfaction (Follow‐up). (A) Responder rate for satisfaction with effect of treatment at day 14. Mean (SD) scores for (B) Satisfaction with Treatment Outcome domain and (C) Satisfaction with Treatment Experience domain. These assessments were evaluated in the mITT population. Dose 1 is either 26 U, 31 U, or 36 U onabotA, and dose 2 is either 52 U, 62 U, or 72 U onabotA. P values were not adjusted for multiplicity and were presented for descriptive purposes only. ANLFQ, Appearance of Neck and Lower Face Questionnaire; mITT, modified intent‐to‐treat; onabotA, onabotulinumtoxinA; PBO, placebo; SD, standard deviation. *p < 0.0001 vs. PBO. † p < 0.05 vs. PBO. ‡ p < 0.001 vs. PBO.
FIGURE 3
FIGURE 3
BAS‐PP Item 1 (Vertical Neck Bands) Responder Rates. These assessments were evaluated in the mITT population. Dose 1 is either 26 U, 31 U, or 36 U onabotA, and dose 2 is either 52 U, 62 U, or 72 U onabotA. P values were not adjusted for multiplicity and were presented for descriptive purposes only. BAS‐PP, Bother Assessment Scale for Platysma Prominence; mITT, modified intent‐to‐treat; onabotA, onabotulinumtoxinA; PBO, placebo. *p < 0.0001 vs. PBO. † p < 0.001 vs. PBO. ‡ p < 0.05 vs. PBO.
FIGURE 4
FIGURE 4
BAS‐PP Item 2 (Jawline) Responder Rates. These assessments were evaluated in the mITT population. Dose 1 is either 26 U, 31 U, or 36 U onabotA, and dose 2 is either 52 U, 62 U, or 72 U onabotA. P values were not adjusted for multiplicity and were presented for descriptive purposes only. BAS‐PP, Bother Assessment Scale for Platysma Prominence; mITT, modified intent‐to‐treat; onabotA, onabotulinumtoxinA; PBO, placebo. *p < 0.0001 vs. PBO. † p < 0.001 vs. PBO. ‡ p < 0.05 vs. PBO.
FIGURE 5
FIGURE 5
PGIS‐Jawline Response Rates. These assessments were evaluated in the mITT population. Dose 1 is either 26 U, 31 U, or 36 U onabotA, and dose 2 is either 52 U, 62 U, or 72 U onabotA. P values were not adjusted for multiplicity and were presented for descriptive purposes only. mITT, modified intent‐to‐treat; onabotA, onabotulinumtoxinA; PBO, placebo; PGIS, Participant Global Impression of Severity. *p < 0.0001 vs. PBO. † p < 0.001 vs. PBO. ‡ p < 0.05 vs. PBO.
FIGURE 6
FIGURE 6
ANLFQ: Impacts. Mean (SD) change from baseline in ANLFQ total score. These assessments were evaluated in the mITT population. Dose 1 is either 26 U, 31 U, or 36 U onabotA, and dose 2 is either 52 U, 62 U, or 72 U onabotA. P values were not adjusted for multiplicity and were presented for descriptive purposes only. ANLFQ, Appearance of Neck and Lower Face Questionnaire; mITT, modified intent‐to‐treat; onabotA, onabotulinumtoxinA; PBO, placebo; SD, standard deviation. *p < 0.0001 vs. PBO. † p < 0.001 vs. PBO. ‡ p < 0.05 vs. PBO.
FIGURE 7
FIGURE 7
Representative images from a 42‐year‐old subject before and after treatment with onabotA. (A) Subject had grade 4 platysma prominence on both sides of the face at baseline based on the C‐APPS. (B) On day 14 after treatment with 36 U of onabotA, the subject achieved a 3‐grade improvement on the C‐APPS on both sides of the face. Reprinted with permission from Rohrich et al. [4]. C‐APPS, Clinician Allergan Platysma Prominence Scale; onabotA, onabotulinumtoxinA.
See this image and copyright information in PMC

References

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