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Study on the Safety and Effectiveness of Dantrolene Sodium and Botulinum Toxin Type A for Treating Severe Glabellar Lines in Adults

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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 treatment of glabellar lines, which are the vertical lines that appear between the eyebrows when frowning. The study will use a combination of two substances: dantrolene sodium and botulinum toxin type A, known together as the FTP-002/FTP-501 combination. These substances are used to help relax muscles and reduce the appearance of these lines. The trial will also involve the use of sodium chloride as a comparison treatment, often referred to as a placebo.

The purpose of the study is to evaluate the safety and effectiveness of the FTP-002/FTP-501 combination in treating severe glabellar lines. Participants will receive a single injection of the treatment, and the study will compare the results of those receiving the combination treatment to those receiving only FTP-002 or a placebo. The study will monitor how well the treatment works and how long the effects last.

Participants will be observed over a period of time to assess any improvements in the appearance of their glabellar lines. The study aims to determine if the treatment can provide a noticeable reduction in the severity of these lines and how long the improvement lasts. The trial will help to understand the potential benefits and any side effects of using the FTP-002/FTP-501 combination for this cosmetic concern.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and assessment

    Upon joining the study, you will attend an initial visit where a healthcare professional will assess the severity of your glabellar lines (the lines between your eyebrows) using a photographic scale. This assessment will be done both by the investigator and by yourself.

    A pregnancy test will be conducted if applicable. You will be asked to provide written informed consent, confirming your understanding and agreement to participate in the study.

  2. Step 2

    Treatment administration

    You will receive a single intramuscular injection of the study medication. This could be either the FTP-002/FTP-501 combination or FTP-002 alone, depending on the group you are assigned to.

    The injection is intended to treat severe glabellar lines. The exact dosage and specific details of the medication will be explained to you by the healthcare professional.

  3. Step 3

    Post-treatment visits

    After the injection, you will have several follow-up visits. During these visits, the healthcare professional will assess the improvement of your glabellar lines using the same photographic scale as before.

    These assessments will help determine the effectiveness of the treatment. You will be asked to report any changes or side effects you experience.

  4. Step 4

    Final assessment

    At the end of the study period, a final assessment will be conducted to evaluate the overall improvement in your glabellar lines.

    The healthcare professional will discuss the results with you and provide any necessary follow-up care or recommendations.

Who can join the trial?

6 criteria

  • Provide written consent to participate in the study.
  • Be a female who has never received any toxin treatments, aged between 18 and 65 years old.
  • Have severe (Grade 3) vertical glabellar lines (the lines between the eyebrows) when frowning, as assessed by a doctor using a special 4-point photographic scale.
  • Have severe (Grade 3) vertical glabellar lines when frowning, as assessed by yourself using a special 4-point photographic scale.
  • If you are a female who can have children, you must have a negative pregnancy test. If you cannot have children due to reasons like having had a hysterectomy (removal of the uterus), or if you are postmenopausal (no periods for 12 months or more without another medical reason), you may be eligible. If you are on hormone replacement therapy, you may need to use non-hormonal birth control or stop the therapy to confirm your postmenopausal status.
  • Be willing and able to follow the study requirements, including attending scheduled visits, following therapy guidelines, and avoiding sun or UV exposure.

Who cannot join the trial?

2 criteria

  • Participants cannot be male. Only females are allowed to participate.
  • Participants must not be part of a vulnerable population. This means they should not be in a situation where they are unable to protect their own interests.
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Investigated drugs

  • FTP-002

    is a medication being tested in this clinical trial to see how well it works and how safe it is for treating severe glabellar lines, which are the frown lines that appear between the eyebrows. This medication is given as a single injection into the muscle. The trial aims to find out if using FTP-002 alone can help reduce these lines and if it is safe for patients.

  • FTP-501

    is another medication involved in the trial, also given as a single injection into the muscle. The purpose of testing FTP-501 is to evaluate its safety and how well it works when used in combination with FTP-002. The researchers want to see if adding FTP-501 to FTP-002 provides better results in reducing severe glabellar lines compared to using FTP-002 by itself.

What is already known about the treatment

  • FTP-002

    FTP-002 is administered as a single intramuscular injection, specifically targeting severe glabellar lines, which are the frown lines between the eyebrows. Currently, it is being studied in clinical trials to assess its safety and effectiveness. The main therapeutic use of FTP-002 is to reduce the appearance of these lines. It works by temporarily relaxing the muscles in the treated area, which helps smooth out the skin. FTP-002 is classified as a neuromodulator, a type of medication that affects nerve signals to muscles.

  • FTP-501

    FTP-501 is also given as a single intramuscular injection and is being tested in combination with FTP-002 for the treatment of severe glabellar lines. This medication is in the exploratory phase of clinical trials to determine its safety and how well it works. The primary purpose of FTP-501 is to enhance the effects of FTP-002, potentially offering a more effective treatment for reducing frown lines. Like FTP-002, it is classified as a neuromodulator, which means it helps relax muscles by altering nerve signals.

Investigated diseases

Glabellar Lines – Glabellar 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 muscles in the forehead, 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 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 aged or tired appearance.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2023-507249-27-00Protocol codeFTP-CLIN-01Estimated enrolment116 patientsSponsorFastox Pharma S.A.

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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).