Face, Rejuvenation, Skin Fold
Conditions
Keywords
Botulinum Toxin, Onabotulinum, Prabotulinum, Upper Third Facial Wrinkles, Botulinum Toxin Comparison, Aesthetic
Brief summary
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.
Detailed description
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.
Interventions
Intramuscular application of onabotulinum toxin-A in the upper facial third.
DRUGPrabotulinumtoxin A
Intramuscular application of prabotulinum toxin-A in the upper facial third.
Sponsors
Instituto de Oftalmología Fundación Conde de Valenciana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Simple randomization was performed in two groups: the Onabotulinum group and the Prabotulinum group. Each group would receive an intramuscular application of onabotulinum toxin-A and prabotulinum toxin-A in the upper facial third, respectively.
Eligibility
Sex/Gender
ALL
Age
25 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* 25 and 40 years of age * Diagnosis of expression lines in the upper facial third of any degree * Wished to improve their aesthetic appearance
Exclusion criteria
* Known allergy to milk protein or albumin * Pregnancy and lactation * Cardiovascular or neuromuscular disease * Recent history of infections in the facial region * Concomitant intake of aminoglycosides or cyclosporine A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in subjective evaluation of botulinum toxin between groups | Pre treatment | 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. |
| Change in objective evaluation of botulinum toxin between groups | Pretreatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of activity | On day 30 | Time of efficacy for muscle blockage on maximun expression |
| Onset of action | On day 7 | Time required from application to muscle blockage on maximum expression |
Countries
Mexico
Outcome results
None listed