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DIFFUSION CHARACTERISTICS OF LETIBOTULINUMTOXIN A IN COMPARISON TO ONA AND ABO-BONTA
EU CTIS ID: 2024-511047-26-01
What this study is testing
The aim of this study is to investigate the spread of three approved botulinum toxin type A preparations with and without complex-forming proteins by measuring and comparing the size of the anhidrotic halos they produce after injection of equivalent doses in an identical volume into the forehead of patients. The focus is on the comparison of letibotulinumtoxinA to onabotulinumtoxinA and abobotulinumtoxinA. In order to make an adequate change between different botulinum toxins possible, the diffusion surface of the toxins is of crucial importance.
- 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
- • Stable health without uncontrolled systemic diseases •Fitzpatrick Skin Type I – VI •Age 18-75 •BMI of 16-27 kg/m2 •Healthy skin testing area •Uniform sweating activity and no areas of anhidrosis under standardized sweating conditions •Moderate to severe wrinkling (in motion) Scale: Forehead Line Rating Scale •Female subjects of childbearing potential must present a negative pregnancy test and commit to using a highly effective method of contraception during the study
You likely can't join if
- • Asymmetrical forehead wrinkles • Active skin lesions/infections or irritations in the treatment area Past surgeries in the forehead area, including surgical removal of the corrugator, procerus or procerus or the supercilian depressor muscle, or a combination of these muscles, or scars in the forehead area, or such surgery is planned during the study • Prior dermal treatment of forehead within 6 months prior to inclusion Prior treatment (upper third of the face) with botulinum toxin of any serotype within 6 months prior to baseline, as well as botulinum toxin for any indication, except investigational drug during the study period • Known hypersensitivity to the study drug or its excipients • Any condition that could pose an increased risk to the subject due to exposure to botulinum toxin, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, marked atrophy or weakness of the target muscles, or any other condition (at the discretion of the investigator) that could impair neuromuscular function or contraindicate botulinum toxin therapy.
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 all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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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.