2024-511047-26-01RecruitingPhase 4
DIFFUSION CHARACTERISTICS OF LETIBOTULINUMTOXIN A IN COMPARISON TO ONA AND ABO-BONTA
Hamburg University1 site in 1 country30 target enrollmentStarted: June 7, 2024Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Maximum anhidrosis area; measured by the halo of anhidrosis
Study Overview
Brief Summary
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.
Study Design
- Allocation
- Randomized
- Primary Purpose
- Diffusion Characteristics Of Letibotulinumtoxin A In Comparison To Ona And Abo-bonta
- Masking
- Double (Subject, Investigator)
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Maximum anhidrosis area; measured by the halo of anhidrosis
Maximum anhidrosis area; measured by the halo of anhidrosis
Secondary Outcomes
- Range of anhidrosis at all other measured time points; Wrinkle Thickness (No Movement / Maximum Tension) measured by Live Evaluation and Evaluation via Standardized Photography; Area under the curve (anhidrosis area) within a period of 6 months; Patient satisfaction; Eyebrow position
Investigators
Clinical trial information desc
Scientific
Hamburg University
Study Sites (1)
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