Efficacy of Prabotulinum and Onabotulinum Toxin-A for Facial Wrinkles

NCT05840445 | Completed Phase 4 DMC

• 1 other identifier: CI-026-2020
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Face; Skin Fold; Rejuvenation

Keywords

Botulinum Toxin; Onabotulinum; Prabotulinum; Upper Third Facial Wrinkles; Botulinum Toxin Comparison; Aesthetic

Outcome Measures

Primary Outcomes (8)

• 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.

  Pre treatment

• 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.

  On day 7

• 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.

  On day 30

• 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.

  On day 120

• 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.

  Pretreatment

• 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.

  On day 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.

  On day 30

• 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.

  On day 120

Secondary Outcomes (3)

• Duration of activity

  On day 30

• Duration of activity

  On day 120

• Onset of action

  On day 7

Study Arms (2)

Onabotulinum Group

PLACEBO COMPARATOR

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

Drug: Onabotulinum toxin A

Prabotulinum Group

ACTIVE COMPARATOR

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

Drug: Prabotulinumtoxin A

Interventions

Onabotulinum toxin A DRUG

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

Also known as: Botox

Onabotulinum Group

Prabotulinumtoxin A DRUG

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

Also known as: Nabota

Prabotulinum Group

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto de Oftalmología Fundación Conde de Valenciana: lead

Study Sites (2)

Institute of Ophthalmology, Conde de Valenciana Foundation

Mexico City, Mexico City, 06800, Mexico

Location

Instituto de Oftalmología

Mexico City, 06800, Mexico

Location

Related Publications (11)

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  PMID: 28145033 BACKGROUND

• 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.

  PMID: 17711532 BACKGROUND

• 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.

  PMID: 21261751 BACKGROUND

• 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.

  PMID: 22964674 BACKGROUND

• 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.

  PMID: 26910696 BACKGROUND

• 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.

  PMID: 31114283 BACKGROUND

• 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.

  PMID: 10906647 BACKGROUND

• 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.

  PMID: 15158548 BACKGROUND

• 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.

  PMID: 26233808 RESULT

• 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.

  PMID: 25311357 RESULT

• 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.

  PMID: 30893169 RESULT

MeSH Terms

Conditions

Facies

Interventions

onabotulinum toxin A; Botulinum Toxins, Type A; prabotulinumtoxin A

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Yonathan Garfias, PhD

  Instituto de Oftalmología Conde de Valenciana I. A. P

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: May 3, 2023
• Study Start: June 15, 2020
• Primary Completion: January 15, 2021
• Study Completion: January 15, 2021
• Last Updated: May 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (2)