Study on the Spread of LetibotulinumtoxinA Compared to OnabotulinumtoxinA and AbobotulinumtoxinA in Patients with Moderate to Severe Forehead Wrinkles

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What is this study about?

This clinical trial is focused on studying the effects of different types of botulinum toxin type A injections on forehead wrinkles. The study involves three specific treatments: Letybo, Botox, and Dysport. These treatments are commonly used to reduce wrinkles by temporarily relaxing the muscles. The main goal of the study is to compare how these treatments spread under the skin and their effectiveness in reducing sweating in the treated area.

Participants in the study will receive injections of these treatments into their foreheads. The study will measure the size of the area where sweating is reduced, known as the anhidrotic halo, after the injections. This will help researchers understand how each treatment spreads and its effectiveness in reducing forehead wrinkles. The study will also look at other factors, such as wrinkle thickness and patient satisfaction, over a period of six months.

The study is designed for individuals with stable health and moderate to severe forehead wrinkles. Participants will be monitored to ensure they have healthy skin and uniform sweating activity. The study aims to provide valuable information on the differences between these treatments, helping to guide future choices in wrinkle reduction therapies.

1 initial assessment

Upon joining the study, an initial assessment will be conducted to ensure eligibility. This includes confirming stable health, healthy skin on the forehead, and moderate to severe forehead wrinkling when moving.

A pregnancy test will be required for female participants of childbearing potential, and a commitment to using a highly effective method of contraception during the study is necessary.

2 injection administration

Participants will receive an injection of one of the three botulinum toxin type A preparations: BOTOX 100, Letybo 50, or Dysport 300. The injection will be administered into the forehead.

The purpose of the injection is to measure and compare the size of the anhidrotic halos, which are areas where sweating is reduced, produced by each preparation.

3 monitoring and evaluation

After the injection, the area of reduced sweating will be monitored. The primary focus is on the maximum area of anhidrosis, which is the area where sweating is reduced.

Secondary evaluations will include the range of anhidrosis at various time points, wrinkle thickness, patient satisfaction, and eyebrow position.

4 follow-up assessments

Follow-up assessments will occur over a period of 6 months to evaluate the area under the curve of anhidrosis and other secondary endpoints.

These assessments will help determine the effectiveness and diffusion characteristics of the botulinum toxin preparations.

Who Can Join the Study?

Be in stable health without any uncontrolled diseases.
Have a Fitzpatrick Skin Type between I and VI. This is a scale that classifies skin types based on their response to sun exposure.
Be between the ages of 18 and 75.
Have a Body Mass Index (BMI) between 16 and 27 kg/m². BMI is a measure of body fat based on height and weight.
Have a healthy skin testing area on the forehead.
Have uniform sweating activity and no areas where sweating is absent under standardized conditions.
Have moderate to severe forehead wrinkling when moving, as measured by the Forehead Line Rating Scale.
If female and capable of becoming pregnant, must have a negative pregnancy test and agree to use a highly effective method of contraception during the study.

Who Cannot Join the Study?

Patients with uncontrolled systemic diseases cannot participate. This means if you have a disease affecting your whole body that is not well-managed, you cannot join.
The skin on your forehead must be healthy. If you have any skin conditions or issues on your forehead, you cannot participate.
You must have moderate to severe forehead wrinkling when you move your forehead. If your forehead does not wrinkle much, you cannot join.
Your forehead must sweat evenly under standard conditions. If you have areas on your forehead that do not sweat at all, you cannot participate.

Where you can join this trial?

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Site Name	City	Country	Status
Hamburg University	Hamburg	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not yet recruiting	08.05.2024

Trial locations

Investigated drugs:

LetibotulinumtoxinA is a type of botulinum toxin used in this study to understand how it spreads in the body. Botulinum toxin is a substance that can relax muscles by blocking nerve signals. In this trial, the researchers are looking at how far this toxin spreads when injected into the forehead. This helps to understand its effectiveness and safety when used for medical or cosmetic purposes.

OnabotulinumtoxinA is another form of botulinum toxin being studied. Like LetibotulinumtoxinA, it is used to relax muscles by stopping nerve signals. The trial aims to compare how this toxin spreads in the body when injected into the forehead, which is important for determining how well it works and how safe it is for patients.

AbobotulinumtoxinA is the third type of botulinum toxin included in the study. It also works by relaxing muscles through blocking nerve signals. The researchers are comparing its spread in the body to the other two toxins when injected into the forehead. Understanding its diffusion is crucial for ensuring its effectiveness and safety in treatments.

Forehead Wrinkling – Forehead wrinkling refers to the lines and creases that appear on the forehead, often as a result of repeated facial expressions such as frowning or raising the eyebrows. Over time, these dynamic wrinkles can become more pronounced and may remain visible even when the face is at rest. The progression of forehead wrinkling is influenced by factors such as age, skin elasticity, and sun exposure. As the skin loses collagen and elasticity with age, wrinkles can deepen and become more noticeable. Environmental factors, such as UV radiation, can accelerate the breakdown of skin structures, contributing to the development of wrinkles. Regular facial movements continue to reinforce these lines, making them a common cosmetic concern.

Trial ID:

2024-511047-26-01

Protocol code:

20231129

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Spread of LetibotulinumtoxinA Compared to OnabotulinumtoxinA and AbobotulinumtoxinA in Patients with Moderate to Severe Forehead Wrinkles

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?