Efficacy of Prabotulinum and Onabotulinum Toxin-A for Facial Wrinkles

April 22, 2023 updated by: Instituto de Oftalmología Fundación Conde de Valenciana

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico, 06800
        • Instituto de Oftalmología
    • Mexico City
      • Mexico, City, Mexico City, Mexico, 06800
        • Institute of Ophthalmology, Conde de Valenciana Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Onabotulinum Group
This group received an intramuscular application of onabotulinum toxin-A in the upper facial third.
Drug: Onabotulinum toxin A
Intramuscular application of onabotulinum toxin-A in the upper facial third.
Other Names:
  • Botox
Active Comparator: Prabotulinum Group
This group received an intramuscular application of prabotulinum toxin-A in the upper facial third.
Drug: Prabotulinumtoxin A
Intramuscular application of prabotulinum toxin-A in the upper facial third.
Other Names:
  • Nabota

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre treatment
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.
On day 7
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.
On day 30
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.
On day 120
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.
Pretreatment
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.
On day 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.
On day 30
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.
On day 120

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of activity
Time Frame: On day 30
Time of efficacy for muscle blockage on maximun expression
On day 30
Duration of activity
Time Frame: On day 120
Time of efficacy for muscle blockage on maximun expression
On day 120
Onset of action
Time Frame: On day 7
Time required from application to muscle blockage on maximum expression
On day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Oftalmología Fundación Conde de Valenciana

Investigators

  • Study Chair: Yonathan Garfias, PhD, Instituto de Oftalmología Conde de Valenciana I. A. P

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2020

Primary Completion (Actual)

January 15, 2021

Study Completion (Actual)

January 15, 2021

Study Registration Dates

First Submitted

April 11, 2023

First Submitted That Met QC Criteria

April 22, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

April 22, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CI-026-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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