Study on the Effects of Botulinum Toxin Type A for Treating Moderate to Severe Forehead Lines in Adults

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What is this study about?

This clinical trial is focused on studying the treatment of moderate and severe horizontal forehead lines, which are the lines that appear on the forehead when raising the eyebrows. The treatment being tested is called LetibotulinumtoxinA, a form of botulinum toxin type A, commonly used to relax muscles. The study will compare the effects of three different dosages of this treatment to see how well they work and how safe they are.

The purpose of the study is to assess how effective and safe these different dosages are in reducing forehead lines. Participants will receive the treatment through an injection into the muscles of the forehead. The study will be conducted over several months, with participants attending multiple visits to monitor their progress. During these visits, the improvement in forehead lines will be evaluated by a specialist who does not know which dosage the participant received. Participants will also be asked about their satisfaction with the treatment and any changes they notice in their appearance.

The study aims to provide valuable information on the best dosage of LetibotulinumtoxinA for treating forehead lines, helping to improve the appearance of these lines safely and effectively. Participants will be monitored closely throughout the study to ensure their well-being and to gather comprehensive data on the treatment’s effects.

1 initial visit and screening

Attend the initial visit, known as the screening visit. During this visit, eligibility for the trial is assessed. This includes confirming understanding of the trial’s purpose and procedures, and providing written consent.

If applicable, a pregnancy test is conducted for women of childbearing potential. This test must be negative to proceed.

The severity of horizontal forehead lines is evaluated using a specific scale, where a score of 3 indicates moderate lines and a score of 4 indicates severe lines.

2 baseline assessment

Participate in a baseline assessment to record initial conditions before treatment. This includes another evaluation of forehead lines and possibly additional tests as required by the trial protocol.

3 treatment administration

Receive the treatment, which involves an intramuscular injection of LetibotulinumtoxinA. The injection is administered into the forehead muscles to address moderate to severe horizontal lines.

The dosage and specific injection pattern are determined by the trial protocol and are blinded, meaning neither the patient nor the evaluator knows which dosage is administered.

4 follow-up visits

Attend follow-up visits at 4, 12, 16, 20, and 24 weeks after the treatment. These visits are crucial for assessing the response to the treatment.

During each visit, the improvement in forehead lines is measured and recorded. This includes a comparison to the baseline assessment using the same scale.

Complete self-assessment questionnaires to evaluate satisfaction with the treatment outcome and the appearance of the forehead and eyebrows.

5 final assessment

Participate in a final assessment at the end of the trial period. This assessment includes a comprehensive evaluation of the treatment’s effectiveness and any changes in the appearance of forehead lines.

Provide feedback on the overall experience and satisfaction with the treatment through additional questionnaires.

Who Can Join the Study?

Subjects who understand the purpose and conduct of the trial and have given written informed consent prior to any trial-related activity and are willing and able to attend the trial visits as judged by the Investigator.
Female subjects aged between 18 and 75 years (75 years inclusive) at Screening visit.
Subjects with moderate or severe dynamic horizontal forehead lines at maximum eyebrow elevation (severity score of 3 or 4 on CDFLAS) as determined by in-clinic assessments by the Blinded Evaluating Investigator (where: 1= ‘none’, 2= ‘mild’, 3= ‘moderate’, 4= ‘severe’, 5= ‘very severe’).
Subjects who wear glasses must be able to adequately self-assess the appearance of their forehead, without glasses obstructing the forehead area.
Subjects with a stable medical condition with no uncontrolled systemic disease (at the Investigator’s discretion).
Women of childbearing potential (WOCBP) must test negative for pregnancy at Screening and Baseline visit and must agree to use highly effective methods of birth control during the trial. This applies for the time period between Screening visit (method used must be working from Screening visit onwards) and until the final trial visit has been completed.

Who Cannot Join the Study?

Only women can participate in this study. Men are not eligible.
Participants must have moderate to severe horizontal forehead lines. If your forehead lines are mild, you cannot participate.
The study is not open to vulnerable populations. This means people who might need special protection or care are not eligible.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hrudecd Aoozstessjzw Bwptigzf Gwok	Vienna	Austria

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	01.10.2024
Germany	Not recruiting	01.10.2024

Trial locations

Investigated drugs:

Botulinum Toxin Type A

LetibotulinumtoxinA is a medication used in this clinical trial to treat horizontal forehead lines, which are the lines that appear on your forehead when you raise your eyebrows. This medication is a type of botulinum toxin, which is commonly used in cosmetic treatments to reduce the appearance of wrinkles. It works by temporarily relaxing the muscles in the forehead, which helps to smooth out the lines and give the skin a more youthful appearance. In this trial, different amounts of the medication are being tested to see which is most effective and safe for reducing these lines.

Horizontal Forehead Lines – Horizontal forehead lines are creases that appear across the forehead, often as a result of repeated facial expressions such as raising the eyebrows. These lines are a common sign of aging and can become more pronounced over time due to the natural loss of skin elasticity. As the skin ages, it produces less collagen and elastin, which are proteins that help maintain skin firmness and elasticity. The progression of these lines can be influenced by factors such as sun exposure, genetics, and lifestyle choices. Over time, these lines may deepen and become more noticeable, contributing to an aged appearance.

Trial ID:

2024-512349-17-00

Protocol code:

CPH-LET01

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of Botulinum Toxin Type A for Treating Moderate to Severe Forehead Lines in Adults

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