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Study on the Effectiveness of Clostridium Botulinum Neurotoxin Type A for Reducing Wrinkles 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 effects of a treatment for wrinkles and fine lines on the face. The treatment being tested is called Bocouture, which contains a substance known as Clostridium botulinum neurotoxin type A. This substance is commonly used in cosmetic procedures to reduce the appearance of wrinkles by temporarily relaxing the muscles.

The purpose of the study is to evaluate how satisfied participants are with the results of the treatment. Participants will receive either the actual treatment or a placebo, which is a substance with no active ingredients. The study will compare the satisfaction levels of those who receive the treatment with those who receive the placebo. The treatment will be administered in split doses, meaning it will be given in smaller amounts but more frequently than usual.

Participants will be involved in the study for a period of time, during which they will receive the treatment and attend follow-up visits. The main focus will be on the change in satisfaction from the beginning of the study to two months after the last treatment. The study will also monitor any adverse events, which are any unexpected or negative reactions to the treatment. The goal is to understand the overall satisfaction with the treatment and its safety.

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 visit

    Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on the inclusion criteria, such as age and health status.

    You will be asked to provide informed consent, indicating your willingness to participate and comply with study requirements.

  2. Step 2

    Baseline assessment

    A baseline assessment will be conducted to evaluate the current condition of your facial wrinkles and fine lines.

    Your satisfaction with your appearance will be measured using the eVAS Satisfaction Scale, which ranges from 0 to 10.

  3. Step 3

    Treatment administration

    You will receive a treatment with either Bocouture or a placebo. Bocouture is a solution for injection containing botulinum toxin.

    The treatment involves split doses administered with double frequency, meaning you will receive injections more frequently than usual.

  4. Step 4

    Follow-up visits

    You will attend several follow-up visits to monitor your response to the treatment.

    These visits will help assess any changes in your satisfaction score and the appearance of your wrinkles.

  5. Step 5

    Final assessment

    A final assessment will be conducted two months after the last treatment.

    Your overall satisfaction will be measured again using the eVAS Satisfaction Scale to determine the effectiveness of the treatment.

  6. Step 6

    Reporting adverse events

    Throughout the study, you are encouraged to report any adverse events or side effects you may experience.

    This information is crucial for evaluating the safety of the treatment.

Who can join the trial?

5 criteria

  • Males or females, 18 to 65 years of age.
  • In general good health.
  • Have symmetrical wrinkles on both sides of the face, with a score of 2 or more in all treatment areas on the Merz Aesthetics Scales. (Symmetrical wrinkles mean that the wrinkles are similar on both sides of the face.)
  • A satisfaction score between 2 and 8 on the eVAS Satisfaction Scale, which ranges from 0 to 10. (This score measures how satisfied you are with your appearance.)
  • Able to participate and willing to give informed consent and follow the study rules. (Informed consent means you understand the study and agree to take part.)

Who cannot join the trial?

6 criteria

  • Participants must not have any **serious skin conditions** other than wrinkles or fine lines. This means no severe skin diseases or infections.
  • Participants should not have any **allergies** to the treatment ingredients. Allergies are when your body reacts badly to certain substances.
  • Participants must not be **pregnant** or **breastfeeding**. This is to ensure the safety of both the mother and the baby.
  • Participants should not have participated in another clinical trial in the last 30 days. This is to avoid any interference with the results of this study.
  • Participants must not have any **medical conditions** that the study doctors think could interfere with the study. This means any health issues that might affect the results or the participant's safety.
  • Participants should not be using any **medications** that could interfere with the study. This means any drugs that might affect the treatment or the results.
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Investigated drugs

Botulinum Toxin is a medication used in this clinical trial. It is a substance that can help relax muscles by blocking nerve signals. In this study, it is being used to see how effective it is when given in smaller amounts but more frequently. The goal is to find out if this method makes people more satisfied with their treatment results. Botulinum toxin is often used to reduce wrinkles or treat muscle-related conditions, and this trial is exploring a new way to use it to improve patient satisfaction.

What is already known about the treatment

Botulinum Toxin – This medication is administered through injections directly into the muscles. It is currently well-established in medical literature and widely used in cosmetic and therapeutic settings. The main therapeutic indication for this medication is the reduction of wrinkles and fine lines. At the molecular level, botulinum toxin works by blocking nerve signals in the muscles, which prevents them from contracting and thus smooths out the skin. It is classified pharmacologically as a neurotoxin.

Investigated diseases

Wrinkles – Wrinkles are lines or creases that form on the skin, often as a result of aging. They occur when the skin loses its elasticity and becomes thinner over time. Factors such as sun exposure, smoking, and repeated facial expressions can accelerate their development. Wrinkles typically start as fine lines and deepen as the skin continues to age. They are most commonly found on areas exposed to the sun, such as the face, neck, and hands. As the skin ages, it produces less collagen and elastin, which are proteins that help maintain its firmness and elasticity, leading to the formation of wrinkles.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2025-520915-14-00Protocol code14031972Estimated enrolment52 patientsSponsorFalck clinic

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).