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
INTRODUCTION: IncobotulinumtoxinA (XeominÂ®/XeomeenÂ®/BocoutureÂ®/XEOMIN Cosmeticâ„¢; 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, 35â€“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 14Â±2, 56Â±7 and 84Â±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.
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 â€“ 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,
Cosmeticâ„¢; 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:
crowâ€™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