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Study Comparing the Effectiveness and Safety of Botulinum Toxin Type A Products for Treating Frown Lines in Adults

Registered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effectiveness and safety of different treatments for glabellar frown lines, which are the wrinkles that appear between the eyebrows. The study will compare five different products that contain botulinum toxin type A, a substance commonly used to reduce wrinkles. The products being tested are NUCEIVA, Azzalure, VISTABEL, BOCOUTURE, and another product with a similar active ingredient. These treatments are administered as injections.

The purpose of the study is to determine which of these products is most effective in reducing the appearance of glabellar frown lines over time. Participants will receive one of the treatments or a placebo and will be monitored to see how long the effects last. The study will also track any side effects and how the treatments impact participants' quality of life, including their psychological wellbeing and social interactions.

Throughout the study, participants will be asked to report on their satisfaction with the treatment and any changes in their anxiety or depression levels. The study will also assess the impact of the treatments on headaches and migraines. The trial is designed to provide clear evidence to help doctors make informed decisions about the best treatment options for reducing glabellar frown lines.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes verifying that you are a woman aged 18 years or over with moderate to severe glabellar lines, and that you meet the American Society of Anesthesiologists (ASA) Physical Status Classification 1 or 2.

  2. Step 2

    Consent and baseline evaluation

    You will be asked to provide written informed consent to participate in the study. A baseline evaluation will be conducted to assess the severity of your glabellar lines using a four-point clinical severity score.

  3. Step 3

    Treatment administration

    You will receive one of the five botulinum toxin type A products: NUCEIVA, Azzalure, VISTABEL, or BOCOUTURE. These are administered as a solution for injection. The specific dosage and frequency will be determined by the study protocol.

  4. Step 4

    Follow-up assessments

    Regular follow-up assessments will be conducted to monitor the treatment's effect on your glabellar lines. The primary outcome measure is the time until the loss of treatment effect, assessed up to week 16.

    Secondary assessments will include monitoring for any adverse events, evaluating quality of life, social functioning, and satisfaction with treatment outcomes using the FACE-Q questionnaire.

  5. Step 5

    Psychological and headache assessments

    Psychological assessments will be conducted from baseline to week 4 using the Hospital Anxiety and Depression Scale (HADS) to monitor changes in anxiety and depression levels.

    The impact on headache and migraine symptoms will be evaluated using the Migraine Disability Assessment (MIDAS) and Headache Impact Test (HIT-6) from baseline to week 4.

  6. Step 6

    Side effects monitoring

    Within the first two weeks, any immediate post-treatment effects on daily life will be evaluated using the FACE-Q Early Life Impact assessment.

Who can join the trial?

3 criteria

  • Women aged 18 years or older, with moderate to severe **glabellar lines** (these are the frown lines or wrinkles that appear between the eyebrows).
  • Willing to provide written **informed consent** (this means you agree to participate in the study after being fully informed about it).
  • Have an **American Society of Anesthesiologists (ASA) Physical Status Classification** of 1 or 2 (this is a system used to assess the fitness of patients prior to surgery; 1 means a normal healthy patient, and 2 means a patient with mild systemic disease).

Who cannot join the trial?

3 criteria

  • Only females can participate in the study. Males are not eligible.
  • Participants must be within a specific age range. If you are outside this range, you cannot join the study.
  • Individuals who are considered part of a vulnerable population cannot participate. This means people who might need special protection or care.
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Investigated drugs

  • Botox

    is a medication used to reduce the appearance of facial wrinkles, specifically the lines between the eyebrows, known as glabellar lines. It works by temporarily relaxing the muscles that cause these lines, leading to a smoother appearance.

  • Dysport

    is another treatment option for reducing glabellar lines. Like Botox, it helps to relax the muscles in the forehead area, which can help to smooth out the wrinkles and give the skin a more youthful look.

  • Xeomin

    is a product used to treat glabellar lines by targeting the muscles that cause these wrinkles. It works similarly to other botulinum toxin products by temporarily reducing muscle activity, which helps to soften the appearance of lines.

  • Jeuveau

    is a treatment designed to improve the look of moderate to severe frown lines between the eyebrows. It acts by relaxing the muscles in this area, which can help to reduce the appearance of these lines.

  • Nuceiva

    is used to treat glabellar lines by temporarily relaxing the muscles that cause these wrinkles. This helps to smooth out the skin and reduce the appearance of lines between the eyebrows.

What is already known about the treatment

Botulinum Neurotoxin Type A – This medication is administered through injections directly into the muscles, specifically targeting areas with glabellar frown lines, commonly known as wrinkles between the eyebrows. It is widely recognized in medical literature and is currently being evaluated in a clinical trial to compare its effectiveness and safety against other similar products. The primary use of this medication is to reduce the appearance of these facial wrinkles. At the molecular level, it works by blocking nerve signals in the muscles, which temporarily reduces muscle activity and smooths out the skin. It is classified as a neuromuscular blocker in pharmacology.

Investigated diseases

Glabellar frown lines – Glabellar frown lines are vertical wrinkles that appear between the eyebrows, often as a result of repeated facial expressions such as frowning. These lines are caused by the contraction of underlying muscles, specifically the corrugator and procerus muscles. Over time, these dynamic lines can become more pronounced and may persist even when the face is at rest. The progression of glabellar frown lines is influenced by factors such as age, skin type, and sun exposure. As the skin loses elasticity with age, these lines can deepen and become more noticeable. They are a common cosmetic concern and are often associated with an appearance of anger or stress.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516865-35-01Estimated enrolment390 patientsSponsorAmsterdam UMC

sourced from the EU Clinical Trials Register and site verification

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