Efficacy of Prabotulinum and Onabotulinum Toxin-A for Facial Wrinkles
Condition: Face; Skin Fold; Rejuvenation
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Onabotulinum toxin A; Prabotulinumtoxin A
Intervention type(s): Drug; Drug
Intervention description(s): Intramuscular application of onabotulinum toxin-A in the upper facial third.; Intramuscular application of prabotulinum toxin-A in the upper facial third.
Other intervention name(s): Botox; Nabota
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Botulinum Toxin; Onabotulinum; Prabotulinum; Upper Third Facial Wrinkles; Botulinum Toxin Comparison; Aesthetic