Reduced Injection Site Pain with Altered pH in 24-h Reconstituted Botulinum Toxin: Findings from a Randomized Controlled Study on Cosmetic Applications

Aesthetic Plast Surg. 2024 Oct 11. doi: 10.1007/s00266-024-04436-w. Online ahead of print.

Abstract

Background: Botulinum toxin (BTX) injections are widely recognized for many cosmetic applications, but still commonly encounter a challenge: injection site pain (ISP). This discomfort can impact the overall patient experience and satisfaction, highlighting a need for innovative solutions to this problem.

Objective: This randomized controlled study aimed to determine whether adjusting the pH levels in a 24-h reconstituted botulinum toxin can serve as a strategy to mitigate ISP.

Methods: A controlled trial involving 24 volunteers was executed. Participants received incobotulinum toxin A. One side of each participant's face was treated with fresh toxin, while the other received a 24-h reconstituted version. Pain perceptions post-injection were assessed using the visual analogue scale (VAS).

Results: pH values of the fresh toxin were more acidic (6.17) than the 24-h reconstituted toxin (7.17). Out of 24 patients, 13 reported reduced ISP with the 24-h reconstituted toxin. The mean VAS score for the fresh toxin was 5.92, in contrast to 4.17 for the reconstituted toxin, indicating a significant difference (p<0.01).

Conclusion: Limitations include the use of a VAS and a relatively small sample size. Altering the pH of BTX demonstrates potential in ISP reduction. However, broader, large-scale investigations are important for comprehensive validation.

Level of evidence iii: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

Keywords: Botulinum toxin; Incobotulinum toxin; Normal saline; Pain; pH value.