Onset, longevity, and patient satisfaction with incobotulinumtoxinA for the treatment of glabellar frown lines: a single-arm, prospective clinical study

Abstract

Background

IncobotulinumtoxinA (Bocouture^®) is free from complexing proteins and effective for treating glabellar frown lines.

Purpose

To determine the efficacy, onset, and duration of action of incobotulinumtoxinA for the treatment of glabellar frown lines.

Patients and methods

In this single-arm, prospective, proof-of-concept study, 23 patients were treated with 25 U incobotulinumtoxinA, equally split between five injection sites in the glabella. Severity of glabellar frown lines was rated by an independent rater from standardized photographs using the validated Merz 5-point scale at several visits over 5 months following treatment. To assess patient satisfaction, patients completed a questionnaire before and 2 weeks after treatment.

Results

The percentage of responders at maximum frown 2–4 days after treatment was 95.2% and 85.0% when responders were defined as patients with ≥1-point and ≥2-point improvement on the 5-point scale compared with baseline, respectively. At this time point, 84% of the maximum effect had occurred. The responder rate at maximum frown, according to both definitions, was 100% for at least the next two visits (days 8 ± 1 and 14 ± 2). At all visits, the change from baseline in the mean glabellar frown-line score at maximum frown was statistically significant, with on average an almost 1-point improvement from baseline 5 months after treatment.

Conclusion

IncobotulinumtoxinA is an effective and well-tolerated treatment for glabellar frown lines, with a rapid onset of action and a long duration of effect lasting for more than 5 months.

Keywords:

• aesthetics
• frown lines
• botulinum toxin A

Acknowledgments/disclosure

Welf Prager has acted as a consultant and lecturer for Allergan Inc, Merz Pharmaceuticals GmbH, and Galderma Pharma SA. Eva K Bee has acted as a consultant and lecturer for Merz Pharmaceuticals GmbH. Isabel Havermann reports no conflicts of interest in this work. Ina Zschocke reports no conflicts of interest in this work. Editorial assistance was provided by Ogilvy 4D, Oxford, UK and funded by Merz Pharmaceuticals GmbH, Frankfurt, Germany.