Head-to-head comparison of six different botox products voor glabellar frown wrinkles.
EU CTIS ID: 2024-516865-35-01
What this study is testing
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).
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.