Head-to-head comparison of six different botox products voor glabellar frown wrinkles.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Stichting Amsterdam UMC

Participant type

Healthy volunteers, Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Decision date (initial)

2025-03-18

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Faceland Holding B.V.

External identifiers

EU CT number

2024-516865-35-01

ClinicalTrials.gov

NCT06448676

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

Clinical Efficacy (Duration) By directly comparing all six commercially available BoNT-A products this trial seeks to provide definitive evidence to inform clinical decision-making and optimize patient outcomes. The primary objective is to compare these products head-to-head in order to determine superiority in clinical efficacy (duration).

Secondary objectives 1

1. The secondary objectives are to compare these products head-to-head in order to determine superiority in safety (adverse events), side-effects, satisfaction with treatment, quality of life, and depressive symptoms.

Conditions and MedDRA coding

Glabellar frown rhytides (wrinkles).

Regulatory references

Plan to share IPD

No

IPD plan description

The data will be pseudonymized. Each participant’s name will be recoded to a non-deductible number (not including date of birth or reference to name) to guarantee privacy. Analogue data documents (CRFs) will be stored in a room which is locked and only accessible with a key available to the researcher. Digital data (SPSS) will be stored on the protected cloud of the Academic Medical Center. In accordance with the “Gedragscode Wetenschapsbeoefening”, data will be stored for at least 15 years.The data will be pseudonymized. Each participant’s name will be recoded to a non-deductible number (not including date of birth or reference to name) to guarantee privacy. Analogue data documents (CRFs) will be stored in a room which is locked and only accessible with a key available to the researcher. Digital data (SPSS) will be stored on the protected cloud of the Academic Medical Center. In accordance with the “Gedragscode Wetenschapsbeoefening”, data will be stored for at least 15 years.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Inclusion Criteria In order to be eligible to participate in this study, a subject must meet all of the following criteria: • Women aged 18 years or over, with moderate to severe glabellar lines. • Willing to provide written informed consent. • American Society of Anesthesiologists (ASA) Physical Status Classification 1 or 2.

Exclusion criteria 1

1. A potential subject who meets any of the following criteria will be excluded from participation in this study: • ASA Classification 3 or over: Patients with a higher ASA score are at increased risk during any medical procedure due to existing severe systemic disease. • History of hypersensitivity or adverse reactions to botulinum toxin or any of its components: To prevent potential allergic reactions or severe side effects. • Infection at the injection site: To avoid exacerbation of infection or interference with the efficacy and safety assessment of the product. • Previous treatment with botulinum toxin (lifetime): To ensure no interference from previous BoNT-A treatments affects study outcomes. • Pregnant or breastfeeding women: To avoid any risk to the developing fetus or newborn. • Peripheral motor neuron diseases (e.g., ALS, Lambert-Eaton syndrome, myopathy) or pre-existing muscle weakness, swallowing or breathing problems: To prevent worsening of symptoms or complications due to underlying neuromuscular instability. • Body Dysmorphic Disorder (assessed with screening tool; Prof. Ad de Jongh; Nederlandse vertaling en bewerking van een screeningslijst t.b.v. cosmetische en chirurgische ingrepen; Cunningham et al., 1998. British Journal of Orthodontics, 25, p.293-298): To exclude individuals who may have unrealistic expectations or psychological issues related to their appearance. • Medications that act on the motor endplate that could potentiate the effect of BoNT-A: This includes aminoglycosides, cholinesterase inhibitors, succinylcholine, curare-like depolarization blockers, magnesium sulfate, quinidine, calcium channel blockers, lincosamides, polymyxins. These drugs could interact with BoNT-A, potentially leading to exaggerated effects or systemic toxicity.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary outcome measure will be the time until loss of treatment effect. This is specifically quantified as the period until a loss of effect is observed and 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.

Secondary endpoints 5

1. Secondary Outcome Related to Clinical Efficacy: (Duration) a. Duration of Treatment Effect (Detailed Analysis): While the primary outcome captures the time until loss of effect at week 16, as secondary outcomes we will employ Kaplan-Meier survival curves and Cox proportional hazards models to analyze the time to complete loss of effect across the entire study duration. This analysis will provide additional insights into the robustness of the treatment's effects, allowing us to identify the media
2. Secondary Outcome Related to Safety: a. Incidence of Adverse Events (AEs): Monitors occurrences of adverse events such as ptosis, strabismus, and eyelid sensory disorders throughout the study period.
3. Patient-Reported Outcomes (assessed from baseline to week 16): a. Quality of Life (FACE-Q Psychological Wellbeing): Evaluates the impact of treatment on psychological wellbeing. b. Social Functioning (FACE-Q Social):44 Assesses the effect of treatment on social interaction capabilities. c. Participant Self-Assessment of Satisfaction (FACE-Q Satisfaction): Measures patient satisfaction with treatment outcomes.
4. Psychological Assessments: a. Hospital Anxiety and Depression Scale (HADS): Assessed from baseline to week 4 to monitor changes in anxiety and depression levels. b. Migraine Disability Assessment (MIDAS) / Headache Impact Test (HIT-6): Assessed from baseline to week 4 to evaluate the impact on headache and migraine symptoms.
5. Side Effects (assessed within the first two weeks): a. FACE-Q Early Life Impact: Evaluates immediate post-treatment effects on patients’ daily life.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Stichting Amsterdam UMC

Sponsor organisation

Stichting Amsterdam UMC

Address

De Boelelaan 1117

City

Amsterdam

Postcode

1081 HV

Country

Netherlands

Scientific contact point

Organisation

Stichting Amsterdam UMC

Contact name

Prof. dr. J. de Lange

Public contact point

Organisation

Stichting Amsterdam UMC

Contact name

Prof. dr. J. de Lange

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 18 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications