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Completed

NCT Number: NCT05840445

Efficacy of Prabotulinum and Onabotulinum Toxin-A for Facial Wrinkles

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.

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Key information

Conditions

Face Disease Attributes Facies Pathologic Processes Pathological Conditions, Signs and Symptoms Rejuvenation Skin Fold

Age range

25 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Institute of Ophthalmology, Conde de Valenciana Foundation, Mexico City, Mexico

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Onabotulinum toxin A

Drug

Intramuscular application of onabotulinum toxin-A in the upper facial third.

Other names: Botox

Prabotulinumtoxin A

Drug

Intramuscular application of prabotulinum toxin-A in the upper facial third.

Other names: Nabota

Primary outcomes

  1. Change in subjective evaluation of botulinum toxin between groups

    Time frame: Pre treatment

    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.

  2. Change in subjective evaluation of botulinum toxin between groups

    Time frame: On day 7

    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.

  3. Change in subjective evaluation of botulinum toxin between groups

    Time frame: On day 30

    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.

  4. Change in subjective evaluation of botulinum toxin between groups

    Time frame: 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.

  5. Change in objective evaluation of botulinum toxin between groups

    Time frame: Pretreatment

    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.

  6. Change in objective evaluation of botulinum toxin between groups

    Time frame: On day 7

    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.

  7. Change in objective evaluation of botulinum toxin between groups

    Time frame: On day 30

    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.

  8. Change in objective evaluation of botulinum toxin between groups

    Time frame: 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 outcomes

  1. Duration of activity

    Time frame: On day 30

    Time of efficacy for muscle blockage on maximun expression

  2. Duration of activity

    Time frame: On day 120

    Time of efficacy for muscle blockage on maximun expression

  3. Onset of action

    Time frame: On day 7

    Time required from application to muscle blockage on maximum expression

Sponsors and collaborators

Lead sponsor

Instituto de Oftalmología Fundación Conde de Valenciana

Other

Registry information

Official study title

Efficacy of Prabotulinum Toxin-A and Onabotulinum Toxin-A for the Treatment of Expression Lines in the Upper Third of the Face.

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 3, 2023
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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