CLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A (150KD), FREE OF COMPLEXING PROTEINS for Glabellar rhytides (glabellar frown lines)

Inclusion criteria

• {"criterion_text":"- 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

• {"criterion_text":"- 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."}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"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 (Honeck)."}

Secondary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Time-to-event analyses using Kaplan-Meier survival curves and Cox proportional hazards models to analyze time to complete loss of effect across the study duration."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Monitoring and recording incidence of adverse events (e.g., ptosis, strabismus, eyelid sensory disorders) throughout study follow-up."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Patient-reported outcome measures (FACE-Q scales) assessed from baseline to week 16 to evaluate psychological wellbeing, social functioning, and treatment satisfaction."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Validated scales (HADS, MIDAS/HIT-6) administered at baseline and week 4 to assess anxiety/depression and headache/migraine impact."}
• {"endpoint_text":"- Side Effects (assessed within the first two weeks): a. FACE-Q Early Life Impact: Evaluates immediate post-treatment effects on patients’ daily life.","definition_or_measurement_approach":"FACE-Q Early Life Impact instrument assessed within first two weeks post-treatment to evaluate immediate impact on daily life."}

Netherlands

Earliest CTIS Part Ii Submission Date

12-02-2025

Latest Decision Or Authorization Date

30-09-2025

Processing Time Days

230

Number Of Sites

5

Number Of Participants

390

Primary sponsor

Full Name

Stichting Amsterdam UMC

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"Faceland Holding B.V.","duties_or_roles":"Monetary support (source of monetary support listed in trial record)","organisation_type":""}