The appearance of facial wrinkles, lines, or folds is a natural phenomenon during aging. Different scales help classify wrinkles objectively, such as the Facial Wrinkle Scale. Others help classify patients' subjective perspectives, like the Face-Q questionnaire. The application of Botulinum Toxin is the most performed non-surgical aesthetic procedure in the world to treat facial expression lines. The present study aims to compare the efficacy of onabotulinum toxin-A (BOTOX®) and prabotulinum toxin-A (NABOTA®) to treat expression lines in the upper third of the face, based on objective and subjective follow-up, using the FWS scale and FACE-Q questionnaire, respectively.
This is an experimental, comparative, longitudinal, open-label, prospective study at the Instituto de Oftalmología Fundación Conde de Valenciana I.A.P, Mexico City, Mexico. The investigators used a proportion formula to calculate the sample size, with an alpha value of 0.05, and a precision of 3%. The difference in the effect between the two toxins is 20%, considering a 20% loss, with a total of 18 patients. A nonprobabilistic sampling of consecutive cases was performed. Once patients were selected and included in the study, they were randomly assigned to a group. After inclusion, simple randomization was performed in the Onabotulinum and Prabotulinum groups. Each group received intramuscular administration of onabotulinum toxin-A and prabotulinum toxin-A in the upper facial third. The investigators used descriptive statistics to analyze the demographic variables and employed the Mann-Whitney U test to assess differences in the quantitative and ordinal outcome variables between the groups before and at the end of the study. Additionally, the investigators employed the chi-square test to compare the intergroup results before and at the end of the study for nominal variables. To compare intragroup results over time, the investigators conducted a repeated measures ANOVA test for continuous variables, Friedman test for ordinal variables, and Cochran's Q test for nominal variables. We used SPSS Version 20 (Chicago, IL, USA) for analysis and considered a value of p\<0.05 as statistically significant.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Intramuscular application of onabotulinum toxin-A in the upper facial third.
Intramuscular application of prabotulinum toxin-A in the upper facial third.
Institute of Ophthalmology, Conde de Valenciana Foundation
Mexico City, Mexico City, Mexico
Instituto de Oftalmología
Mexico City, Mexico
Change in subjective evaluation of botulinum toxin between groups
Evaluation using Face-Q questionnaire on each visit, answered by the patient. Questionnaire-based Likert scale with a min value of 1 and maximum value of 4, qualifying patient's satisfaction with their facial appearance.
Time frame: Pre treatment
Change in subjective evaluation of botulinum toxin between groups
Evaluation using Face-Q questionnaire on each visit, answered by the patient. Questionnaire-based Likert scale with a min value of 1 and maximum value of 4, qualifying patient's satisfaction with their facial appearance.
Time frame: On day 7
Change in subjective evaluation of botulinum toxin between groups
Evaluation using Face-Q questionnaire on each visit, answered by the patient. Questionnaire-based Likert scale with a min value of 1 and maximum value of 4, qualifying patient's satisfaction with their facial appearance.
Time frame: On day 30
Change in subjective evaluation of botulinum toxin between groups
Evaluation using Face-Q questionnaire on each visit, answered by the patient. Questionnaire-based Likert scale with a min value of 1 and maximum value of 4, qualifying patient's satisfaction with their facial appearance.
Time frame: On day 120
Change in objective evaluation of botulinum toxin between groups
Evaluation using Facial Wrinkle Scale on each visit, made by the main author. It is an objective scale with four points, minimum score 0, none; 1, mild; 2, moderate; and maximum score 3, severe.
Time frame: Pretreatment
Change in objective evaluation of botulinum toxin between groups
Evaluation using Facial Wrinkle Scale on each visit, made by the main author. It is an objective scale with four points, minimum score 0, none; 1, mild; 2, moderate; and maximum score 3, severe.
Time frame: On day 7
Change in objective evaluation of botulinum toxin between groups
Evaluation using Facial Wrinkle Scale on each visit, made by the main author. It is an objective scale with four points, minimum score 0, none; 1, mild; 2, moderate; and maximum score 3, severe.
Time frame: On day 30
Change in objective evaluation of botulinum toxin between groups
Evaluation using Facial Wrinkle Scale on each visit, made by the main author. It is an objective scale with four points, minimum score 0, none; 1, mild; 2, moderate; and maximum score 3, severe.
Time frame: On day 120
Duration of activity
Time of efficacy for muscle blockage on maximun expression
Time frame: On day 30
Duration of activity
Time of efficacy for muscle blockage on maximun expression
Time frame: On day 120
Onset of action
Time required from application to muscle blockage on maximum expression
Time frame: On day 7
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