BOTULINUM TOXIN TYPE A for Forehead wrinkling | Focal hyperhidrosis (forehead)

Inclusion criteria

• {"criterion_text":"- Stable health without uncontrolled systemic diseases"}
• {"criterion_text":"- Fitzpatrick Skin Type I – VI"}
• {"criterion_text":"- Age 18-75"}
• {"criterion_text":"- BMI of 16-27 kg/m2"}
• {"criterion_text":"- Healthy skin testing area"}
• {"criterion_text":"- Uniform sweating activity and no areas of anhidrosis under standardized sweating conditions"}
• {"criterion_text":"- Moderate to severe wrinkling (in motion) Scale: Forehead Line Rating Scale"}
• {"criterion_text":"- 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

• {"criterion_text":"- Asymmetrical forehead wrinkles"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Known hypersensitivity to the study drug or its excipients"}
• {"criterion_text":"- 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."}

Primary endpoints

• {"endpoint_text":"- Maximum anhidrosis area; measured by the halo of anhidrosis","definition_or_measurement_approach":"Measured by the halo of anhidrosis (size of anhidrotic halo produced after injection)."}

Secondary endpoints

• {"endpoint_text":"- Range of anhidrosis at all other measured time points","definition_or_measurement_approach":""}
• {"endpoint_text":"- Wrinkle Thickness (No Movement / Maximum Tension) measured by Live Evaluation and Evaluation via Standardized Photography","definition_or_measurement_approach":"Measured by live evaluation and standardized photography assessing wrinkle thickness at no movement and maximum tension."}
• {"endpoint_text":"- Area under the curve (anhidrosis area) within a period of 6 months","definition_or_measurement_approach":"Area under the curve of anhidrosis area over 6 months."}
• {"endpoint_text":"- Patient satisfaction","definition_or_measurement_approach":""}
• {"endpoint_text":"- Eyebrow position","definition_or_measurement_approach":""}

Germany

Earliest CTIS Part Ii Submission Date

22-03-2024

Latest Decision Or Authorization Date

07-06-2024

Processing Time Days

77

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Hamburg University

Organisation Type

Educational Institution

Country Of Registered Address

Germany