Efficacy of Prabotulinum and Onabotulinum Toxin-A for Facial Wrinkles

Instituto de Oftalmología Fundación Conde de Valenciana

Status and phase: Completed; Phase 4

Conditions: Face; Rejuvenation; Skin Fold

Treatments: Drug: Prabotulinumtoxin A; Drug: Onabotulinum toxin A

Study type: Interventional

Funder types: Other

Identifiers

NCT05840445

CI-026-2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 25 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups, including a placebo group

Onabotulinum Group

Placebo Comparator group

Description:

This group received an intramuscular application of onabotulinum toxin-A in the upper facial third.

Treatment:

Drug: Onabotulinum toxin A

Prabotulinum Group

Active Comparator group

Description:

This group received an intramuscular application of prabotulinum toxin-A in the upper facial third.

Treatment:

Drug: Prabotulinumtoxin A