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FacePhase 4NCT05840445

Efficacy of Prabotulinum and Onabotulinum Toxin-A for Facial Wrinkles

A Phase 4 study testing Onabotulinum toxin A and Prabotulinumtoxin A in people with Face and Skin Fold, run by Instituto de Oftalmología Fundación Conde de Valenciana at 2 sites in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Face, Skin Fold, Rejuvenation
What is being tested?
Onabotulinum toxin A and Prabotulinumtoxin A
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
26 participants
Where
2 sitesMexico
Study dates
15 Jun 2020to 15 Jan 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 25 and 40 years of age
  • Diagnosis of expression lines in the upper facial third of any degree
  • Wished to improve their aesthetic appearance

Who cannot join

  • 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 locations and contacts

2 sites in 1 country.

Mexico2 sites

  • Institute of Ophthalmology, Conde de Valenciana Foundation

    Mexico City, Mexico City, 06800

  • Instituto de Oftalmología

    Mexico City, 06800

Other trials in Mexico

About this study

Official title: 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.

Read the 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.

Being tested
Onabotulinum toxin A, Prabotulinumtoxin A
Keywords
Botulinum Toxin, Onabotulinum, Prabotulinum, Upper Third Facial Wrinkles, Botulinum Toxin Comparison, Aesthetic
Medical subject headings
Facies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Onabotulinum toxin ADrug

    Also called Botox

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

  • Prabotulinumtoxin ADrug

    Also called Nabota

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

Study groups in NCT05840445
Study groupRoleWhat they receive
Onabotulinum GroupPlacebo comparatorThis group received an intramuscular application of onabotulinum toxin-A in the upper facial third.
Receives: Drug: Onabotulinum toxin A
Prabotulinum GroupActive comparatorThis group received an intramuscular application of prabotulinum toxin-A in the upper facial third.
Receives: Drug: Prabotulinumtoxin A

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in subjective evaluation of botulinum toxin between groups

    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.

    Measured: Pre treatment

  2. Change in subjective evaluation of botulinum toxin between groups

    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.

    Measured: On day 7

  3. Change in subjective evaluation of botulinum toxin between groups

    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.

    Measured: On day 30

  4. Change in subjective evaluation of botulinum toxin between groups

    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.

    Measured: On day 120

  5. Change in objective evaluation of botulinum toxin between groups

    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.

    Measured: Pretreatment

  6. Change in objective evaluation of botulinum toxin between groups

    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.

    Measured: On day 7

  7. Change in objective evaluation of botulinum toxin between groups

    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.

    Measured: On day 30

  8. Change in objective evaluation of botulinum toxin between groups

    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.

    Measured: On day 120

Secondary outcomes (3)

  1. Duration of activity

    Time of efficacy for muscle blockage on maximun expression

    Measured: On day 30

  2. Duration of activity

    Time of efficacy for muscle blockage on maximun expression

    Measured: On day 120

  3. Onset of action

    Time required from application to muscle blockage on maximum expression

    Measured: On day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2023
  2. Study start15 Jun 2020
  3. Primary completion15 Jan 2021
  4. Study completion15 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05840445
Sponsor's protocol ID
CI-026-2020
Status last verified
Apr 2023
First submitted
11 Apr 2023
Last updated
3 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hadi H, Wilkinson CM. Categorizing facial creases: A review. J Cosmet Dermatol. 2017 Jun;16(2):180-185. doi: 10.1111/jocd.12305. Epub 2017 Feb 1.

    PubMed 28145033

  • Yaar M, Gilchrest BA. Photoageing: mechanism, prevention and therapy. Br J Dermatol. 2007 Nov;157(5):874-87. doi: 10.1111/j.1365-2133.2007.08108.x. Epub 2007 Aug 17.

    PubMed 17711532

  • Kohl E, Steinbauer J, Landthaler M, Szeimies RM. Skin ageing. J Eur Acad Dermatol Venereol. 2011 Aug;25(8):873-84. doi: 10.1111/j.1468-3083.2010.03963.x. Epub 2011 Jan 24.

    PubMed 21261751

  • Conkling N, Bishawi M, Phillips BT, Bui DT, Khan SU, Dagum AB. Subjective rating of cosmetic treatment with botulinum toxin type A: do existing measures demonstrate interobserver validity? Ann Plast Surg. 2012 Oct;69(4):350-5. doi: 10.1097/SAP.0b013e31824a43e0.

    PubMed 22964674

  • Sundaram H, Signorini M, Liew S, Trindade de Almeida AR, Wu Y, Vieira Braz A, Fagien S, Goodman GJ, Monheit G, Raspaldo H; Global Aesthetics Consensus Group. Global Aesthetics Consensus: Botulinum Toxin Type A--Evidence-Based Review, Emerging Concepts, and Consensus Recommendations for Aesthetic Use, Including Updates on Complications. Plast Reconstr Surg. 2016 Mar;137(3):518e-529e. doi: 10.1097/01.prs.0000475758.63709.23.

    PubMed 26910696

  • Satriyasa BK. Botulinum toxin (Botox) A for reducing the appearance of facial wrinkles: a literature review of clinical use and pharmacological aspect. Clin Cosmet Investig Dermatol. 2019 Apr 10;12:223-228. doi: 10.2147/CCID.S202919. eCollection 2019.

    PubMed 31114283

  • Huang W, Foster JA, Rogachefsky AS. Pharmacology of botulinum toxin. J Am Acad Dermatol. 2000 Aug;43(2 Pt 1):249-59. doi: 10.1067/mjd.2000.105567.

    PubMed 10906647

  • Klein AW. Contraindications and complications with the use of botulinum toxin. Clin Dermatol. 2004 Jan-Feb;22(1):66-75. doi: 10.1016/j.clindermatol.2003.12.026.

    PubMed 15158548

  • Nam HS, Park YG, Paik NJ, Oh BM, Chun MH, Yang HE, Kim DH, Yi Y, Seo HG, Kim KD, Chang MC, Ryu JH, Lee SU. Efficacy and safety of NABOTA in post-stroke upper limb spasticity: a phase 3 multicenter, double-blinded, randomized controlled trial. J Neurol Sci. 2015 Oct 15;357(1-2):192-7. doi: 10.1016/j.jns.2015.07.028. Epub 2015 Jul 21.

    PubMed 26233808

  • Won CH, Kim HK, Kim BJ, Kang H, Hong JP, Lee SY, Kim CS. Comparative trial of a novel botulinum neurotoxin type A versus onabotulinumtoxinA in the treatment of glabellar lines: a multicenter, randomized, double-blind, active-controlled study. Int J Dermatol. 2015 Feb;54(2):227-34. doi: 10.1111/ijd.12627. Epub 2014 Oct 14.

    PubMed 25311357

  • Cheon HI, Jung N, Won CH, Kim BJ, Lee YW. Efficacy and Safety of Prabotulinumtoxin A and Onabotulinumtoxin A for Crow's Feet: A Phase 3, Multicenter, Randomized, Double-Blind, Split-Face Study. Dermatol Surg. 2019 Dec;45(12):1610-1619. doi: 10.1097/DSS.0000000000001920.

    PubMed 30893169

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Onabotulinum toxin A and Prabotulinumtoxin A in people with Face and Skin Fold, run by Instituto de Oftalmología Fundación Conde de Valenciana at 2 sites in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in subjective evaluation of botulinum toxin between groups (time frame: Pre treatment). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05840445, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.

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