Efficacy of Prabotulinum and Onabotulinum Toxin-A for Facial Wrinkles

Phase 4

Completed

• Conditions: Face; Rejuvenation; Skin Fold
• Interventions: Drug: Onabotulinum toxin A; Drug: Prabotulinumtoxin A

• Registration Number: NCT05840445
• Lead Sponsor: Instituto de Oftalmología Fundación Conde de Valenciana

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.

Study Timeline

• Study Start: 2020-06-15
• Primary Completion: 2021-01-15
• Study Completion: 2021-01-15
• Status Verified: 2023-04
• Study First Submitted: 2023-04-11
• Study First Submitted QC: 2023-04-22
• Last Update Submitted: 2023-04-22
• Study First Posted: 2023-05-03
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Onabotulinum Group	Onabotulinum toxin A	This group received an intramuscular application of onabotulinum toxin-A in the upper facial third.
Prabotulinum Group	Prabotulinumtoxin A	This group received an intramuscular application of prabotulinum toxin-A in the upper facial third.

Primary Outcome Measures

Name	Time	Method
Change in subjective evaluation of botulinum toxin between groups	On day 120	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	On day 120	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 Outcome Measures

Name	Time	Method
Duration of activity	On day 120	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

Trial Locations

Locations (2)

Institute of Ophthalmology, Conde de Valenciana Foundation; 🇲🇽 Mexico, City, Mexico City, Mexico

Instituto de Oftalmología; 🇲🇽 Mexico City, Mexico