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| Name | Class |
|---|---|
| Universitair Medical Centrum Groningen | UNKNOWN |
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Study Type: This is a multicenter, triple-blind, randomized controlled trial.
Purpose: The goal of this clinical trial is to compare the effectiveness and safety of all commercially available Botulinum Neurotoxin Type A (BoNT-A) products for treating glabellar rhytides, commonly known as frown lines. This study is designed to provide comprehensive data on how these treatments compare in terms of improving frown lines and the duration of their effects.
Main Questions the Study Aims to Answer:
Which BoNT-A product provides the longest lasting effect on reducing glabellar rhytides? How do these products compare in terms of safety and the occurrence of side effects?
Participant Tasks:
Women aged 18 years or older with moderate to severe glabellar lines will participate.
Participants will receive injections of a BoNT-A product into specific facial muscles.
They will need to take weekly photographs using their smartphones to document changes in their frown lines.
These photos will be securely sent to our research team for analysis. Participants will complete questionnaires at the start and end of the study to assess their satisfaction, quality of life, and any changes in their condition.
Comparison Group:
Researchers will compare participants receiving different types of BoNT-A products to see which one is more effective at reducing frown lines and maintaining these effects over time.
The safety profiles of these products will also be compared to determine which has the fewest and least severe side effects.
This study aims to fill important gaps in our understanding of Botulinum Neurotoxin Type A treatments, guiding more effective clinical decisions and improving patient outcomes.
Background: Glabellar rhytides, commonly known as frown lines, are a significant aesthetic concern for many individuals, leading to increasing utilization of Botulinum Neurotoxin Type A (BoNT-A) treatments. Despite multiple products being available, comprehensive comparative data on their efficacy and safety are limited. This trial aims to fill this evidence gap by evaluating and comparing the effectiveness and safety profiles of all five FDA-approved BoNT-A products.
Methods: Conducted across several clinical sites, this multicenter, double-blind, randomized controlled trial will involve a structured intervention where participants receive one of the different BoNT-A formulations. The study employs a stringent blinding and randomization process to ensure the objectivity and reliability of the results. Data on treatment efficacy, safety, and participant-reported outcomes will be collected at baseline and follow-up through direct clinical assessments and secure digital communication methods.
Data Collection and Analysis: Data collection will include baseline and 16-week follow-up assessments using standardized clinical scales and self-reported question anaires. Participants will document 30 weekly progress through standardized 'selfie' photos using a secure, encrypted application to ensure data privacy. The primary outcome, the duration of treatment efficacy, will be analyzed using Kaplan-Meier survival analysis. Secondary outcomes, including the incidence of adverse events and participant satisfaction, will be analyzed using repeated measures ANOVA and logistic regression. Detailed duration of effect will be assessed using Kaplan-Meier curves and Cox proportional hazards models.
Statistical Analysis: The study is powered to detect meaningful clinical differences between the treatment groups with a high degree of statistical confidence. The analysis will explore treatment effects over time and assess factors influencing treatment efficacy and safety.
Conclusion: By rigorously comparing all available BoNT-A products, this study will provide critical insights into their relative effectiveness and safety, significantly informing clinical decision-making and optimizing patient care strategies for treating glabellar lines. The findings are expected to enhance the understanding of treatment dynamics and guide future therapeutic approaches in aesthetic medicine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OnabotulinumtoxinA: 20 units | Active Comparator | 20 units (4-4-4-4-4) Commercial Name: Botox® Producing Company: Allergan, an AbbVie company Location: Dublin, Ireland Additional Commercial Names: Vistabel® (in some regions, especially Europe) |
|
| IncobotulinumtoxinA: 20 units | Active Comparator | 20 units (4-4-4-4-4) Commercial Name: Xeomin® Producing Company: Merz Pharmaceuticals Location: Frankfurt, Germany Additional Commercial Names: Bocouture® (for aesthetic use in some regions) |
|
| AbobotulinumtoxinA: 50 (Speywood) units | Active Comparator | 50 units (10-10-10-10-10) Commercial Name: Dysport® Producing Company: Ipsen Biopharmaceuticals, Inc. Location: Paris, France Additional Commercial Names: Azzalure® (for aesthetic use in some regions) |
|
| AbobotulinumtoxinA: 60 (Speywood) units | Active Comparator | 60 units (12-12-12-12-12) Commercial Name: Dysport® Producing Company: Ipsen Biopharmaceuticals, Inc. Location: Paris, France Additional Commercial Names: Azzalure® (for aesthetic use in some regions) |
|
| PrabotulinumtoxinA 20 units | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A | Drug | Head-to-head comparison of all commercially available botulinum neurotoxin type A products |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Clinical Efficacy | Period until loss of treatment effect, measured as the percentage of participants who maintain at least a 1-point improvement in glabellar line severity at maximum frown from baseline to week 16, assessed using the "four-point clinical severity score for glabellar frown lines" developed by Honeck. | From baseline to week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Clinical Efficacy | Median time to loss of effect | Kaplan-Meier survival curves and Cox proportional hazards models to analyze the time to complete loss of effect across the entire study duration (From baseline to week 30) |
| Incidence of Adverse Events (AEs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Serge A. Steenen, MD DMD | Contact | +316 26 457 415 | s.a.steenen@amsterdamumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Jan de Lange, MD DMD PhD | Amsterdam UMC, location VUmc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faceland | Recruiting | Amsterdam | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29444367 | Background | Decates T, de Wijs L, Nijsten T, Velthuis P. Numbers on injectable treatments in the Netherlands in 2016. J Eur Acad Dermatol Venereol. 2018 Aug;32(8):e328-e330. doi: 10.1111/jdv.14877. Epub 2018 Mar 6. No abstract available. | |
| 34403196 | Background | Decates TS, Velthuis P, Zarringam D, Bruin L, Schepers RH, van der Lei B. Upward trend in number of injectable treatments in the Netherlands 2016-2019. J Cosmet Dermatol. 2021 Sep;20(9):3049-3051. doi: 10.1111/jocd.14339. Epub 2021 Jul 19. No abstract available. |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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This study is a double-blind, multi-center, parallel-group randomized controlled trial designed to compare the efficacy and safety of onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA, and prabotulinumtoxinA, for the treatment of glabellar rhytides.
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Trial participants, data collectors, the statistician, and outcome assessors were blinded to the study-group assignments. Blinded syringes are labeled a sticker containing no information other than the allocated study number. After reconstitution, syringes were stored under hygienic non-sterile conditions between 39-46F in medical refrigerators. The safety related to this sterile transfer is substantiated by several studies.
20 units (4-4-4-4-4) Commercial Name: Jeuveau® Producing Company: Evolus, Inc. Location: Newport Beach, California, USA Additional Commercial Names: Nuceiva® (for aesthetic use in some regions) |
|
Occurrences of adverse events such as ptosis, strabismus, and eyelid sensory disorders throughout the study period |
| From baseline to week 16 |
| Quality of Life (FACE-Q) | FACE-Q Psychological Wellbeing Scores, (values 10-40), higher score means a better outcome | From baseline to week 16 |
| Social Functioning (FACE-Q) | FACE-Q Social Scores, (values 8-32), higher score means a better outcome | From baseline to week 16 |
| Satisfaction with the Result (FACE-Q) | FACE-Q Outcome Scores, (values 6-24), higher score means a better outcome | From baseline to week 16 |
| Depressive Symptoms | Hospital Anxiety and Depression Scale (HADS) Depression Scores, (values 0-21), higher score means a worse outcome | Baseline to week 4 |
| Anxiety Symptoms | Hospital Anxiety and Depression Scale (HADS) Anxiety Scores, (values 0-21), higher score means a worse outcome | Baseline to week 4 |
| Migraine Symptoms | Migraine Disability Assessment (MIDAS) Scores, (values 0-21+), higher score means a worse outcome | Baseline to week 4 |
| Headache Symptoms | Headache Impact Test (HIT-6) Scores, (values 36-78), higher score means a worse outcome | Baseline to week 4 |
| Side Effects (FACE-Q) | FACE-Q Early Life Impact Scores, (values 17-68), higher score means a worse outcome | First 2 weeks after treatment |
| Faceland | Recruiting | Eindhoven | Netherlands |
|
| Faceland | Recruiting | Utrecht | Netherlands |
|
| 35953448 | Background | Steenen SA, Bauland CG, de Lange J, van der Lei B. Complications After Botulinum Neurotoxin Type A and Dermal Filler Injections: Data From a Large Retrospective Cohort Study. Aesthet Surg J. 2023 Jan 9;43(1):NP56-NP63. doi: 10.1093/asj/sjac228. No abstract available. |
| 27495260 | Background | Jia Z, Lu H, Yang X, Jin X, Wu R, Zhao J, Chen L, Qi Z. Adverse Events of Botulinum Toxin Type A in Facial Rejuvenation: A Systematic Review and Meta-Analysis. Aesthetic Plast Surg. 2016 Oct;40(5):769-77. doi: 10.1007/s00266-016-0682-1. Epub 2016 Aug 5. |
| 34456155 | Background | Zargaran D, Zoller FE, Zargaran A, Mosahebi A. Complications of facial cosmetic botulinum toxin A injection: analysis of the UK Medicines & Healthcare Products Regulatory Agency registry and literature review. J Plast Reconstr Aesthet Surg. 2022 Jan;75(1):392-401. doi: 10.1016/j.bjps.2021.05.074. Epub 2021 Jun 17. |
| 35353777 | Background | Gostimir M, Liou V, Yoon MK. Safety of Botulinum Toxin A Injections for Facial Rejuvenation: A Meta-Analysis of 9,669 Patients. Ophthalmic Plast Reconstr Surg. 2023 Jan-Feb 01;39(1):13-25. doi: 10.1097/IOP.0000000000002169. Epub 2022 Mar 30. |
| 35178552 | Background | Zargaran D, Zoller F, Zargaran A, Rahman E, Woollard A, Weyrich T, Mosahebi A. Complications of Cosmetic Botulinum Toxin A Injections to the Upper Face: A Systematic Review and Meta-Analysis. Aesthet Surg J. 2022 Apr 12;42(5):NP327-NP336. doi: 10.1093/asj/sjac036. |
| 36097079 | Background | Li X, Sui C, Xia X, Chen X. Efficacy and Safety of Botulinum Toxin Type A for Treatment of Glabellar Lines: A Network Meta-Analysis of Randomized Controlled Trials. Aesthetic Plast Surg. 2023 Feb;47(1):365-377. doi: 10.1007/s00266-022-03018-y. Epub 2022 Sep 12. |
| 34636520 | Background | Kerscher M, Fabi S, Fischer T, Gold M, Joseph J, Prager W, Rzany B, Yoelin S, Roll S, Klein G, Maas C. IncobotulinumtoxinA Demonstrates Safety and Prolonged Duration of Effect in a Dose-Ranging Study for Glabellar Lines. J Drugs Dermatol. 2021 Oct 1;20(10):1052-1060. doi: 10.36849/JDD.6377. |
| 32722793 | Background | Polacco MA, Singleton AE, Barnes CH, Maas C, Maas CS. A Double-Blind, Randomized Clinical Trial to Determine Effects of Increasing Doses and Dose-Response Relationship of IncobotulinumtoxinA in the Treatment of Glabellar Rhytids. Aesthet Surg J. 2021 May 18;41(6):NP500-NP511. doi: 10.1093/asj/sjaa220. |
| 34491016 | Background | Joseph J, Moradi A, Lorenc ZP, Coleman K, Ablon G, Kaufman-Janette J, Cox SE, Campbell A, Dayan S, Berg AK, Munavalli G. AbobotulinumtoxinA for the Treatment of Moderate-to-Severe Glabellar Lines: A Randomized, Dose-Escalating, Double-Blind Study. J Drugs Dermatol. 2021 Sep 1;20(9):980-987. doi: 10.36849/jdd.6263. |
| 33944913 | Background | Lorenc ZP, Adelglass JM, Avelar RL, Baumann L, Beer KR, Cohen JL, Cox SE, Dayan SH, Dover JS, Downie JB, Draelos ZD, Goldman MP, Gross JE, Joseph JH, Kaufman-Janette J, Moy RL, Nestor M, Schlessinger J, Smith SR, Weiss RA. The Second of Two One-Year, Multicenter, Open-Label, Repeat-Dose, Phase II Safety Studies of PrabotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines in Adult Patients. Aesthet Surg J. 2021 Nov 12;41(12):1423-1438. doi: 10.1093/asj/sjaa382. |
| 33165078 | Background | Taylor SC, Grimes PE, Joseph JH, Jonker A, Avelar RL. PrabotulinumtoxinA for the Treatment of Moderate-to-Severe Glabellar Lines in Adult Patients With Skin of Color: Post Hoc Analyses of the US Phase III Clinical Study Data. Dermatol Surg. 2021 Apr 1;47(4):516-521. doi: 10.1097/DSS.0000000000002864. |
| 35266281 | Background | Dayan S, Joseph J, Moradi A, Lorenc ZP, Coleman K, Ablon G, Kaufman-Janette J, Cox SE, Campbell A, Munavalli G, Prygova I. Subject satisfaction and psychological well-being with escalating abobotulinumtoxinA injection dose for the treatment of moderate to severe glabellar lines. J Cosmet Dermatol. 2022 Jun;21(6):2407-2416. doi: 10.1111/jocd.14906. Epub 2022 Apr 12. |
| 31791824 | Background | Bertucci V, Solish N, Kaufman-Janette J, Yoelin S, Shamban A, Schlessinger J, Snyder D, Gallagher C, Liu Y, Shears G, Rubio RG. DaxibotulinumtoxinA for Injection has a prolonged duration of response in the treatment of glabellar lines: Pooled data from two multicenter, randomized, double-blind, placebo-controlled, phase 3 studies (SAKURA 1 and SAKURA 2). J Am Acad Dermatol. 2020 Apr;82(4):838-845. doi: 10.1016/j.jaad.2019.06.1313. Epub 2019 Nov 29. |
| 36370906 | Background | Steenen SA, Bauland CG, van der Lei B, Su N, van Engelen MDG, Anandbahadoer-Sitaldin RDRRAL, Koeiman W, Jawidan T, Hamraz Y, Lange J. Head-to-head comparison of 4 hyaluronic acid dermal fillers for lip augmentation: A multicenter randomized, quadruple-blind, controlled clinical trial. J Am Acad Dermatol. 2023 Apr;88(4):932-935. doi: 10.1016/j.jaad.2022.11.012. Epub 2022 Nov 9. No abstract available. |
| 31135088 | Background | Shome D, Kapoor R, Khare S. Two different types of botulinum toxins: Is there a difference in efficacy and longevity? J Cosmet Dermatol. 2019 Dec;18(6):1635-1641. doi: 10.1111/jocd.12949. Epub 2019 May 28. |
| 38447766 | Background | Bohart Z, Dashtipour K, Kim H, Schwartz M, Zuzek A, Singh R, Nelson M. Real-world differences in dosing and clinical utilization of OnabotulinumtoxinA and AbobotulinumtoxinA in the treatment of upper limb spasticity. Toxicon. 2024 Apr;241:107678. doi: 10.1016/j.toxicon.2024.107678. Epub 2024 Mar 4. |
| 12932236 | Background | Honeck P, Weiss C, Sterry W, Rzany B; Gladys study group. Reproducibility of a four-point clinical severity score for glabellar frown lines. Br J Dermatol. 2003 Aug;149(2):306-10. doi: 10.1046/j.1365-2133.2003.05436.x. |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |