Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05840445
Status:
COMPLETED
Last Update Posted:
2023-05-03
First Post:
2023-04-11
Brief Title:
Efficacy of Prabotulinum and Onabotulinum Toxin-A for Facial Wrinkles
Sponsor:
Instituto de Oftalmología Fundación Conde de Valenciana
Organization:
Instituto de Oftalmología Fundación Conde de Valenciana
Study Overview
Official Title:
Efficacy of Prabotulinum Toxin-A and Onabotulinum Toxin-A for the Treatment of Expression Lines in the Upper Third of the Face
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 IAP Mexico City Mexico
The investigators used a proportion formula to calculate the sample size with an alpha value of 005 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 Cochrans Q test for nominal variables We used SPSS Version 20 Chicago IL USA for analysis and considered a value of p005 as statistically significant
The investigators used a proportion formula to calculate the sample size with an alpha value of 005 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 Cochrans Q test for nominal variables We used SPSS Version 20 Chicago IL USA for analysis and considered a value of p005 as statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None