Efficacy of Prabotulinum and Onabotulinum Toxin-A for Facial Wrinkles

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Prabotulinum Toxin-A and Onabotulinum Toxin-A for the Treatment of Expression Lines in the Upper Third of the Face.

Conditions
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Face, Skin Fold, Rejuvenation

Intervention / Treatment
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* Drug: Onabotulinum toxin A
* Drug: Prabotulinumtoxin A


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Onabotulinum Group<br>This group received an intramuscular application of onabotulinum toxin-A in the upper facial third. | Drug: Onabotulinum toxin A<br>* Intramuscular application of onabotulinum toxin-A in the upper facial third.<br>* Other names: Botox;|
| Active Comparator: Prabotulinum Group<br>This group received an intramuscular application of prabotulinum toxin-A in the upper facial third. | Drug: Prabotulinumtoxin A<br>* Intramuscular application of prabotulinum toxin-A in the upper facial third.<br>* Other names: Nabota;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | On day 120 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of activity | Time of efficacy for muscle blockage on maximun expression | On day 30 | 
| Duration of activity | Time of efficacy for muscle blockage on maximun expression | On day 120 | 
| Onset of action | Time required from application to muscle blockage on maximum expression | On day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Botulinum Toxin, Onabotulinum, Prabotulinum, Upper Third Facial Wrinkles, Botulinum Toxin Comparison, Aesthetic