Clinical trial NCT05840445: Efficacy of Prabotulinum and Onabotulinum Toxin-A for Facial Wrinkles
Official title: Efficacy of Prabotulinum Toxin-A and Onabotulinum Toxin-A for the Treatment of Expression Lines in the Upper Third of the Face.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Face
Skin Fold
Rejuvenation
Keywords: Botulinum Toxin
Onabotulinum
Prabotulinum
Upper Third Facial Wrinkles
Botulinum Toxin Comparison
Aesthetic
Lead sponsor: Instituto de Oftalmología Fundación Conde de Valenciana
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 26
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in subjective evaluation of botulinum toxin between groups
timeFrame: Pre treatment
measure: Change in subjective evaluation of botulinum toxin between groups
timeFrame: On day 7
measure: Change in subjective evaluation of botulinum toxin between groups
timeFrame: On day 30
measure: Change in subjective evaluation of botulinum toxin between groups
timeFrame: On day 120
measure: Change in objective evaluation of botulinum toxin between groups
timeFrame: Pretreatment
measure: Change in objective evaluation of botulinum toxin between groups
timeFrame: On day 7
measure: Change in objective evaluation of botulinum toxin between groups
timeFrame: On day 30
measure: Change in objective evaluation of botulinum toxin between groups
timeFrame: On day 120
Secondary outcomes:
measure: Duration of activity
timeFrame: On day 30
measure: Duration of activity
timeFrame: On day 120
measure: Onset of action
timeFrame: On day 7
Other outcomes:
Locations:
city: Mexico, City
country: Mexico
facility: Institute of Ophthalmology, Conde de Valenciana Foundation
state: Mexico City
city: Mexico City
country: Mexico
facility: Instituto de Oftalmología
Study officials:
affiliation: Instituto de Oftalmología Conde de Valenciana I. A. P
name: Yonathan Garfias, PhD
role: STUDY_CHAIR
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