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Corabotase for Moderate to Severe Glabellar Lines in Adults

Verified siteInvestigationalNo 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 being done to see how well IPN10200 works and how safe it is for adults with moderate to severe glabellar lines, which are the wrinkle-like lines between the eyebrows. The study treatment is CORABOTASE, given as a single intramuscular injection, meaning it is injected into a muscle. Some participants will receive a placebo during the first part of the study. The study also compares repeated doses over time to learn more about the longer-term effects of the treatment.

The study has two main parts. In the first part, participants receive one injection and are followed for several weeks to see how the lines change and how safe the treatment is. In the second part, some participants may receive more injections over time in an open-label phase, which means the treatment given is known. During the study, the face and general health are checked, and possible side effects are watched closely. Blood tests may also be done to look for antibodies, which are proteins the body can make against a medicine.

The study focuses on whether the lines between the eyebrows become less noticeable after treatment and whether the treatment remains safe with repeated use. It also looks at how long the effect lasts and how often repeat treatment may be needed.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study start and first treatment

    After joining the study, you enter the double-blind phase. Double-blind means that neither you nor the study staff know whether you receive the study medicine or placebo.

    You receive a single dose of IPN10200 or placebo as a solution for injection by intramuscular use (an injection into a muscle). The study medicine is CORABOTASE. The placebo is an inactive powder used to match the study treatment.

    The dose of CORABOTASE is listed as 0.00 ng in the source data. The source data does not provide any other dose, frequency, or duration details for the first treatment.

  2. Step 2

    Days 1 to 8 after treatment

    During days 1 to 8, you use a participant diary to record when treatment response begins. This is used to measure the time to onset of treatment response.

  3. Step 3

    Week 4 visit

    At week 4, your face is checked to see whether the lines between your eyebrows have improved.

    The assessment is done at maximum frown, which means the strongest frown you can make.

    In North America, improvement is measured by both the study doctor’s rating and your own rating. In Europe and the rest of the world, improvement is measured by the study doctor’s rating only.

    The study looks for at least a 2-grade improvement from the start of the study. A grade is a level used to describe how severe the lines are.

    The study also checks whether the lines are rated as none or mild.

  4. Step 4

    Post-treatment checks during the double-blind phase

    After treatment, you have repeated visits during the double-blind phase to check how your lines look over time.

    At these visits, the study may assess whether the lines are rated as none or mild by the study doctor at maximum frown.

    At these visits, you may also rate the lines yourself at maximum frown.

    The study may check for a 2-grade improvement, a 1-grade improvement, and whether the lines at rest improve by 1 grade.

    The study may also ask whether you are very satisfied or satisfied with the treatment.

    You may complete questionnaires about how your face looks and how the lines affect how you feel.

    The study checks how long it takes for a person who improved to return to a rating of moderate or severe lines.

    The study also checks for side effects, changes in vital signs such as pulse, blood pressure, and temperature, changes in ecg (a heart tracing test), and changes in facial, nerve, and physical examinations.

    Blood tests are used to check for antibodies against IPN10200 at week 4.

  5. Step 5

    Week 12 visit

    At week 12, your face is checked again using the same rating methods used earlier.

    The study checks for improvement in the appearance of the lines at maximum frown.

    The study may also repeat the self-rating and the satisfaction questions.

    Side effects, vital signs, and facial, nerve, and physical examinations are checked again.

    Blood tests are used to check for antibodies against IPN10200 at week 12.

  6. Step 6

    Week 24 visit

    At week 24, the study repeats the checks of the line appearance at maximum frown.

    The study checks response to treatment and side effects over time.

    Blood tests are used to check for antibodies against IPN10200 at week 24.

  7. Step 7

    Week 36 visit, if retreatment is not yet allowed

    At week 36, you may have another visit if you are not yet eligible for retreatment.

    The study repeats the same checks of line appearance, side effects, vital signs, and facial, nerve, and physical examinations.

    Blood tests are used to check for antibodies against IPN10200 at week 36 if retreatment is not yet allowed.

  8. Step 8

    Week 52 visit and end of the double-blind phase

    At week 52, the double-blind phase ends.

    The study again checks the appearance of the lines, side effects, vital signs, and facial, nerve, and physical examinations.

    Blood tests are used to check for antibodies against IPN10200 at week 52.

  9. Step 9

    Open-label phase and repeat treatment cycles

    After the double-blind phase, you enter the open-label phase. Open-label means that the study treatment is known.

    You may receive repeat doses of IPN10200 in treatment cycles. The source data does not give the dose amount, frequency, or the exact number of repeat doses.

    The study measures the time between two consecutive injections.

    After each injection, the study repeats the same types of checks used earlier: appearance of the lines at maximum frown, self-rating, satisfaction questions, questionnaires about appearance and psychological function, side effects, and checks of vital signs and facial, nerve, and physical examinations.

    Blood tests are used to check for antibodies against IPN10200 at week 4, week 12, week 24, week 36, week 52 of each cycle, and at the end of study.

Who can join the trial?

12 criteria

  • Be an adult, meaning 18 years of age or older when signing the informed consent form. Informed consent means the person agrees to join the study after being told about it.
  • Be either male or female.
  • Have moderate or severe glabellar lines at rest and when frowning at the start of the study. Glabellar lines are the lines between the eyebrows.
  • Have the lines between the eyebrows rated as Grade 2 or Grade 3 on a 4-point scale by the study doctor. A 4-point scale is a rating system with four levels.
  • Have the lines between the eyebrows rated as Grade 2 or Grade 3 on another 4-point scale by the study doctor.
  • Be dissatisfied or very dissatisfied with the appearance of the lines between the eyebrows at the start of the study.
  • For women, use birth control in a way that follows the local rules for clinical studies.
  • Be able to sign the informed consent form and agree to follow all study rules and limits.
  • Have enough time and be able to follow the study schedule and instructions.
  • Not live in an institution by order of a court or government, such as a prison or similar facility.
  • Not be an employee of the sponsor or of the clinical research team directly involved in the study.
  • Not be an immediate family member of someone directly involved in the study. Immediate family means a spouse, parent, child, or sibling, whether related by birth or legal adoption.

Who cannot join the trial?

26 criteria

  • An active infection or other skin problems in the upper face, including the area between the eyebrows, such as acne spots that are inflamed or ulcers (open sores).
  • A history of eyelid surgery to remove extra skin or fat from the eyelids (blepharoplasty), a brow lift, or any other upper face surgery within the past 5 years.
  • A history of facial nerve palsy, which means weakness or paralysis of the facial nerve.
  • Noticeable facial asymmetry (one side of the face looks different from the other), ptosis (drooping of the eyelid or upper face), too much loose eyelid skin (dermatochalasis), deep skin scars, or very thick oily skin.
  • Closed-angle glaucoma or a higher risk of getting it, for participants in Japan.
  • Any known medical condition that could increase risk from botulinum toxin (BoNT, a medicine that relaxes muscles), such as myasthenia gravis (a disease that causes muscle weakness), Eaton-Lambert syndrome, or amyotrophic lateral sclerosis (a nerve and muscle disease, also called ALS).
  • Scars, piercings, or tattoos in or around the treatment area, including eyebrow microblading, that were done within the past 6 months, or that the investigator thinks could affect the study results.
  • Use of any botulinum toxin treatment other than the study treatment anywhere in the body within 9 months before the first study visit and until the end of the study.
  • Any previous treatment with IPN10200 in another study.
  • Use of medicines that affect how nerves and muscles work, such as certain muscle relaxants, lincosamides, polymyxins, or anticholinesterases, within 30 days before the start of the study, unless a longer break is needed for a long-lasting medicine.
  • Use of aminoglycoside antibiotics within 30 days before the start of the study. These are a group of antibiotics; topical use away from the injection area is allowed.
  • Use of systemic retinoids within 30 days before the start of the study or planned use during the study. Systemic means taken by mouth or by another body-wide route. Topical retinoids may be allowed if they are not used in the upper face, depending on the investigator’s decision.
  • Any past treatment with permanent fillers, lifting threads, autologous fat (the person’s own fat), or other permanent procedures in the upper face, including the area between the eyebrows.
  • Use of nonpermanent injectables such as hyaluronic acid, calcium hydroxylapatite, poly-L-lactic acid, or polymethyl-methacrylate for adding volume in the area between the eyebrows within 12 months before the study.
  • Any facial treatment or cosmetic procedure to the upper face within the past 3 months, such as photorejuvenation (light-based skin treatment), vascular laser treatment for blood vessels, pigment laser treatment for skin color, or microneedling (tiny needles used on the skin).
  • Any upper face treatment within the past 12 months that involved skin resurfacing (treatments that remove or smooth the top layers of skin), including dermabrasion, laser treatment, or a chemical peel.
  • Any planned cosmetic surgery or aesthetic procedure to the upper face during the study, or any procedure on other parts of the face that the investigator thinks could affect the study results.
  • Any past surgery in the upper facial line area, including the area between the eyebrows.
  • Planned use of other medicines or treatments that the investigator thinks could interfere with the study results. Medicines or treatments needed for the participant’s health may still be allowed at the investigator’s decision.
  • Use of any experimental device within 30 days before the study, or use of any experimental drug within the required washout period before the study. A washout period means time without the medicine so it can leave the body.
  • Positive test for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV), or a diagnosis of acquired immunodeficiency syndrome (AIDS).
  • A clinically diagnosed significant anxiety disorder or any other major psychiatric disorder, such as depression, that could affect study participation.
  • Not being able to reduce the glabellar lines enough, as judged by the investigator.
  • A known allergy or hypersensitivity to BoNT or any ingredient in IPN10200. Hypersensitivity means an unusual or strong reaction to a substance.
  • A history of drug abuse, whether chronic or recreational, as judged by the investigator.
  • Any uncontrolled systemic disease or other serious medical condition that could make study participation unsafe or could harm the participant during the study.
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Investigated drugs

CORABOTASE is the study treatment being tested in this trial. It is given as an injection into a muscle and is being evaluated to see if it can improve the look of moderate to severe frown lines between the eyebrows. The trial is checking how well it works, how long the effect lasts, and whether it is safe when used once and then again over time.

What is already known about the treatment

Corabotase - Corabotase is given as a solution for injection into a muscle, which means it is administered by intramuscular use. It is an investigational substance, so it is still being studied and is not yet a standard approved medicine in regular medical practice. In this trial, it is being tested for the treatment of moderate to severe glabellar lines, which are the frown lines between the eyebrows. It is a biologic agent that is expected to work by blocking nerve signals to the small facial muscles, helping them relax so the lines become less visible.

Investigated diseases

Glabellar Lines - Glabellar lines are the vertical or frown lines that appear between the eyebrows and above the nose. They usually become more noticeable with repeated facial movement, especially frowning or squinting, and can deepen over time as the skin loses elasticity. Mild lines may be seen only when the face is moving, while more advanced lines can remain visible even when the face is relaxed.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522618-22-00Protocol codeCLIN-10200-458Estimated enrolment1 300 patientsSponsorIpsen Innovation

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).