Efficacy and Safety of IncobotulinumtoxinA for the Treatment of Platysmal Bands of the Aging Neck: An Open-Label, Prospective Pilot Study

December 2013 | Volume 12 | Issue 12 | Original Article | 1461 | Copyright © December 2013

Elena I. Gubanova MD,a Olga S. Panova MD,b Elena A. Sanchez MD,b
Maria Y. Rodina MD,a and Polina A. Starovatovaa

aVallex M, Clinic of Preventive Medicine, Moscow, Russia
bEclan, Medical Center of Cosmetological Correction, Moscow, Russia

Abstract
INTRODUCTION: IncobotulinumtoxinA (Xeomin®/Xeomeen®/Bocouture®/XEOMIN Cosmetic™; botulinum toxin type A, free from complexing proteins [150 kDa], NT 201; Merz Pharmaceuticals GmbH, Frankfurt, Germany) is an effective and well-tolerated treatment for a variety of facial wrinkles.
OBJECTIVE: To determine the efficacy and safety of incobotulinumtoxinA for the treatment of platysmal bands.
METHODS: Women, 35–65 years of age, with platysmal bands scoring 2 or 3 on the validated 5-point Merz dynamic platysmal bands scale received a total of 60 U incobotulinumtoxinA divided between four platysmal bands (20 U in both medial bands and 10 U in both lateral bands). Investigator assessments according to the 5-point scale were made at baseline and from standardized clinical photographs taken at follow-up visits 14±2, 56±7 and 84±7 days after treatment. The global aesthetic improvement scale (GAIS) and a novel questionnaire were used to assess subject treatment satisfaction. Adverse events were recorded.
RESULTS: Twenty-five women (mean age 51.8 years) were included in the study. With a responder defined as a subject with at least a 1-point improvement from baseline on the dynamic platysmal bands scale, the response rate at maximum contraction was 100% at Day 14 as assessed by the investigator. By the same definition, a high response rate (96%) was maintained at maximum contraction at Day 84. Subjects reported that, at Day 84, 86.3% of the maximal effect (defined as the effect on Day 14) persisted. Subject-reported satisfaction was high, as indicated by the self-assessment on the GAIS and results from the subject satisfaction questionnaire. Treatment- related adverse events were mild and reversible.
CONCLUSION: IncobotulinumtoxinA is an effective, well-tolerated treatment for platysmal bands, with a high percentage of the treatment effect maintained at 3 months after treatment. Investigator and subject assessments both indicated high levels of treatment satisfaction.

J Drugs Dermatol. 2013;12(12):1461-1466.

INTRODUCTION

A slim and smooth neck is considered youthful, with loss of neck, chin and jaw line definition considered by some as an unwelcome sign of aging.1-3 Banding of the platysma muscle in the neck, a consequence of chronic muscular contraction and skin laxity,1, 3 usually starts to appear during the late 30s in both sexes.4 Historically, the only option to improve the appearance of platysmal banding has been surgery – either an isolated procedure or one performed as part of face-lifting. Frequently, however, platysmal bands reappear within 1 year.4
Non-invasive techniques are now being used for the aging neck. These include non-ablative photorejuvenation using laser or intense pulse light, dermal fillers, and botulinum toxins, which weaken the injected muscle and can be targeted specifically to the platysmal bands (Prager et al, manuscript in preparation).2,5,6 The botulinum toxin type A (BoNT/A), incobotulinumtoxinA, (Xeomin®/Xeomeen®/Bocouture®/XEOMIN Cosmetic™; BoNT/A, free from complexing proteins [150 kDa],NT 201; Merz Pharmaceuticals GmbH, Frankfurt, Germany) has shown efficacy in the treatment of glabellar frown lines,7,8 and is licensed for this indication widely across Europe and in the USA, Canada, Argentina, Brazil, and South Korea. In Russia and Mexico it is licensed for the treatment of mimic wrinkles and hyperkinetic facial lines, respectively. IncobotulinumtoxinA has also demonstrated efficacy in other aesthetic indications: crow’s feet,9 forehead lines10 and upper facial lines.11
The aim of the clinical study reported here was to assess the efficacy and safety of incobotulinumtoxinA injections into the platysmal bands for neck rejuvenation.

MATERIALS AND METHODS

This prospective open-label study was performed in two centres in Russia and conducted in accordance with local and international regulations. Informed consent was obtained from each participant.