Efficacy of Prabotulinum and Onabotulinum Toxin-A for Facial Wrinkles
NCT ID: NCT05840445
Last Updated: 2023-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
26 participants
INTERVENTIONAL
2020-06-15
2021-01-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Assess Adverse Events and Effectiveness of OnabotulinumtoxinA Intramuscular Injections for the Change of Moderate to Severe Forehead Lines in Adult Participants
NCT06794866
Botulinum Toxin A Single Blind Split-Face Randomized Pilot Study
NCT02907268
Safety and Efficacy Study of Botulinum Toxin Type A to Treat Glabellar Lines
NCT01485601
A Safety and Efficacy Study of OnabotulinumtoxinA in Forehead and Glabellar Facial Rhytides
NCT02261467
A Safety and Efficacy Study of OnabotulinumtoxinA in Upper Facial Rhytides
NCT02261493
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Onabotulinum Group
This group received an intramuscular application of onabotulinum toxin-A in the upper facial third.
Onabotulinum toxin A
Intramuscular application of onabotulinum toxin-A in the upper facial third.
Prabotulinum Group
This group received an intramuscular application of prabotulinum toxin-A in the upper facial third.
Prabotulinumtoxin A
Intramuscular application of prabotulinum toxin-A in the upper facial third.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Onabotulinum toxin A
Intramuscular application of onabotulinum toxin-A in the upper facial third.
Prabotulinumtoxin A
Intramuscular application of prabotulinum toxin-A in the upper facial third.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosis of expression lines in the upper facial third of any degree
* Wished to improve their aesthetic appearance
Exclusion Criteria
* Pregnancy and lactation
* Cardiovascular or neuromuscular disease
* Recent history of infections in the facial region
* Concomitant intake of aminoglycosides or cyclosporine A
25 Years
40 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Instituto de Oftalmología Fundación Conde de Valenciana
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yonathan Garfias, PhD
Role: STUDY_CHAIR
Instituto de Oftalmología Conde de Valenciana I. A. P
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Institute of Ophthalmology, Conde de Valenciana Foundation
Mexico City, Mexico City, Mexico
Instituto de Oftalmología
Mexico City, , Mexico
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CI-026-2020
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.