I Chajchir1, P Modi, A Chajchir. 1. Cirugia Plastica Estetica, Centro Medico Barrancas, Buenos Aires, Argentina. irina.chajchir@fibertel.com.ar
Abstract
BACKGROUND: This study aimed to compare the effect of the stabilized novel topical botulinum neurotoxin type A (BoNTA) cream (CosmeTox) and a placebo cream on subjects, to compare clinician-reported outcomes, and to assess the safety and utility of the novel topical BoNTA cream for treating the entire upper face, chin, and neck areas. METHODS: This study randomized 40 female subjects to receive eithertopical BoNTA (CosmeTox) cream (2 U/ml) or an identical placebo cream (without BoNTA) on the face, chin, and neck areas. The subjects were followed for 12 weeks. The main outcome measures were the Facial Line Outcomes questionnaire scores and results from the Self-Perception of Age instrument, which assesses age of appearance relative to actual age. RESULTS: The BoNTA topical cream (CosmeTox) treatment produced significant improvements in the Facial Lines Outcome scores, which were maintained throughout the study period and lasted more than 3 months. The BoNTA topical cream treatment also reduced the age of appearance for a majority of subjects. The placebo had no effect on any measure. No serious adverse events occurred during the entire study period. CONCLUSION: Topical treatment with the stabilized BoNTA cream (CosmeTox) to the entire upper facial lines resulted in significantly improved facial features and age appearance, as measured by the subjects and clinicians. The BoNTA cream (CosmeTox) resulted in a significantly younger, more satisfying, relaxed appearance.
RCT Entities:
BACKGROUND: This study aimed to compare the effect of the stabilized novel topical botulinum neurotoxin type A (BoNTA) cream (CosmeTox) and a placebo cream on subjects, to compare clinician-reported outcomes, and to assess the safety and utility of the novel topical BoNTA cream for treating the entire upper face, chin, and neck areas. METHODS: This study randomized 40 female subjects to receive either topical BoNTA (CosmeTox) cream (2 U/ml) or an identical placebo cream (without BoNTA) on the face, chin, and neck areas. The subjects were followed for 12 weeks. The main outcome measures were the Facial Line Outcomes questionnaire scores and results from the Self-Perception of Age instrument, which assesses age of appearance relative to actual age. RESULTS: The BoNTA topical cream (CosmeTox) treatment produced significant improvements in the Facial Lines Outcome scores, which were maintained throughout the study period and lasted more than 3 months. The BoNTA topical cream treatment also reduced the age of appearance for a majority of subjects. The placebo had no effect on any measure. No serious adverse events occurred during the entire study period. CONCLUSION: Topical treatment with the stabilized BoNTA cream (CosmeTox) to the entire upper facial lines resulted in significantly improved facial features and age appearance, as measured by the subjects and clinicians. The BoNTA cream (CosmeTox) resulted in a significantly younger, more satisfying, relaxed appearance.
Authors: Elena Fonfria; Jacquie Maignel; Stephane Lezmi; Vincent Martin; Andrew Splevins; Saif Shubber; Mikhail Kalinichev; Keith Foster; Philippe Picaut; Johannes Krupp Journal: Toxins (Basel) Date: 2018-05-18 Impact factor: 4.546