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RecruitingNCT07779252LAURITE 3Updated Sep 14, 2026

A Study to Assess the Effectiveness and Safety of IPN10200 in Adult Chinese Participants With Moderate to Severe Wrinkle-like Lines Between the Eyebrows

A Phase 3 interventional study of Corabotase and Placebo in Moderate to Severe Glabellar Lines, sponsored by Ipsen. Recruiting at 9 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Ipsen · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to find out about the effectiveness and safety of a single dose of corabotase (also known as IPN10200) compared to placebo works in participants with moderate to severe glabellar lines. Glabellar lines are wrinkle-like lines that appear between the eyebrows and can become more noticeable with age or repeated facial expressions. They may affect a person's appearance and confidence.

In this study, all participants will receive a single injection of either corabotase (the study drug) or placebo. There will be 3 periods in this study:

  • A screening period (up to 20 days) to assess whether the participant can take part, requiring at least 1 visit to the study centre.
  • A treatment period (Day 1) where all the eligible participants will receive a single injection of corabotase or placebo.
  • A follow-up period (52 weeks) where participants' health will be monitored, consisting of regular visits to the study centre and 1 telephone call visit.

Participants will undergo health measurements and observation, including blood sampling, physical examinations, and clinical evaluations. They will also be asked to fill in questionnaires and keep a diary. Each participant will be in this study for up to 55 weeks. Participants may withdraw consent to participate at any time.

02

Conditions studied

  • Moderate to Severe Glabellar Lines
03

In context

Lead sponsor

Ipsen is the lead sponsor of 289 studies on the registry; 17 are open to participants now.

Of its 26 completed or terminated interventional studies of FDA-regulated products, 22 (85%) have results posted.

Browse Ipsen studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participant should be male or female, ≥18 years of age inclusive at the time of signing the ICF.
  • Moderate or severe (Grade 2 or 3) GL at MF at baseline, as assessed by the ILA using a validated 4-point photographic scale.
  • Moderate or severe (Grade 2 or 3) GL at MF at baseline, as assessed by the SSA using a 4-point categorical scale.
  • Dissatisfied or very dissatisfied (Grade 2 or 3) with their lines at baseline, as assessed by the SLS.
  • If female participants: use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Capable of giving signed which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
  • Participant has both the time and the ability to complete the study and comply with study instructions.
  • Is not a sponsor employee or clinical research unit personnel directly affiliated with the study or is not an immediate family member. Immediate family is defined as a spouse, parent, child or sibling whether biological or legally adopted.

Exclusion criteria

Exclusion Criteria:

  • An active infection or other skin problems in the upper face including the GL area (e.g. acute acne lesions or ulcers).
  • A history of eyelid blepharoplasty or brow lift or any other upper facial surgery within the past 5 years.
  • A history of facial nerve palsy.
  • Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring or thick sebaceous skin.
  • Presence of any scars, piercings or tattoos (including micro blading of the eyebrows) in or around the treatment area that have occurred within 6 months prior to baseline, or which in the investigator's opinion, could interfere with evaluations.
  • Any known medical condition that may put the participant at increased risk in regard to exposure to BoNT of any serotype (i.e. myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, etc.).
  • Closed-angle glaucoma or a predisposition to it.
  • Participants who have received IPN10200 in a previous study.
  • Administration of any BoNT (other than the study intervention at the baseline visit) into any site of the body and for any indication from 9 months prior to the first study visit until the EOS
  • Use of medications that affect neuromuscular transmission (such as curare-like nondepolarising agents, lincosamides, polymyxins, anticholinesterases) within the past 30 days prior to baseline are prohibited or a longer of at least five half-lives might be required, as deemed appropriate by the investigator for long-acting medications.
  • Use of aminoglycoside antibiotics within the past 30 days prior to baseline are prohibited. Note: Topical use apart from the area of injection would be acceptable.
  • Use of systemic retinoids within the past 30 days prior to baseline and planned use during the study. Note: Topical retinoids are allowed other than in the areas that will be injected (upper facial area) at the discretion of the investigator.
  • Any prior treatment with permanent fillers, lifting threads, autologous fat or permanent procedures in the upper face including the GL area.
  • Administration of any non-permanent injectables (such as hyaluronic acid, calcium hydroxylapatite, poly-L-Lactic acid or polymethyl-methacrylate) soft tissue augmentation therapy in the GL region within 12 months prior to baseline.
  • Any prior facial treatment or aesthetic procedures to the upper face including photo rejuvenation, vascular or pigment laser or microneedling within the 3 months prior to baseline.
  • Any prior facial treatment or aesthetic procedures to the upper face involving skin resurfacing (including dermabrasion, laser or whatever the interventional technique used) or chemical peel within the past 12 months prior to baseline.
  • Any planned cosmetic surgery or aesthetic procedures to the upper face during the study and/or any procedures to other parts of the face which in the investigator's opinion, could interfere with evaluations during the study.
  • Any past surgery in the UFL area including GL.
  • Planned use of concomitant therapy which, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study intervention. Therapy considered necessary for the participant's welfare may be given at the discretion of the investigator. Note: If the permissibility of a specific medication/treatment is in question, the medical monitor will be contacted.
  • Use of any experimental device within 30 days prior to baseline visit or use of any treatment with an experimental drug within five times the documented terminal half-life of the respective drug or its metabolites or if the half-life is unknown within 30 days prior to the start of the study (prior to baseline visit) and during the conduct of the study.
  • Known positive for antigen, virus antibody or for or a diagnosis of acquired immunodeficiency syndrome.
  • Clinically diagnosed significant anxiety disorder, or any other significant psychiatric disorder (e.g. depression) that might interfere with the participant's participation in the study.
  • An inability to substantially lessen GL as determined by the investigator.
  • Known allergy or to BoNT or any of IPN10200.
  • A history of chronic or recreational drug abuse as assessed by the investigator.
  • Any uncontrolled systemic disease or other significant medical condition which would be harmful for the participant to be entered into the study or continue participation.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
160 participants (estimated)

Study arms

  • Experimental
    Corabotase group

    Participants will receive corabotase through injections into the selected muscles on Day 1.

    Biological: Corabotase

  • Placebo comparator
    Placebo group

    Participants will receive placebo through injections into the selected muscles on Day 1.

    Biological: Placebo

Interventions

  • BiologicalCorabotase

    A single vial of lyophilised powder for solution for injection will be injected locally into several sites across the glabellar region.

    Also known as: IPN10200

  • BiologicalPlacebo

    A single vial of lyophilised powder for solution, containing excipients without active substance, will be injected locally into several sites across the glabellar region.

06

What researchers measure

Primary outcomes

  1. Percentage of participants responding to treatment

    Measured by the multicomponent response of ≥2-grade improvement from baseline and a score of 'None' or 'Mild' on Investigator's Live Assessment (ILA) and Subject's Self-Assessment (SSA) at maximum frown. ILA: a validated 4-point photographic scale used to assess the severity and appearance of glabellar lines at maximum frown, where grade 0 = "None," grade 1 = "Mild," grade 2 = "Moderate," and grade 3 = "Severe." SSA: a 4-point categorical scale used to assess the appearance of glabellar lines at maximum frown, where grade 0 = "No wrinkles," grade 1 = "Mild wrinkles," grade 2 = "Moderate wrinkles," and grade 3 = "Severe wrinkles.

    Time frame: At Week 4

Secondary outcomes

  1. Percentage of participants responding to treatment as measured by a score of 'None' or 'Mild' at Week 24 on the ILA at maximum frown.

    ILA: a validated 4-point photographic scale used to assess the severity and appearance of glabellar lines at maximum frown, where grade 0 = "None," grade 1 = "Mild," grade 2 = "Moderate," and grade 3 = "Severe."

    Time frame: At Week 24

  2. Percentage of participants responding to treatment

    Measured by the multicomponent response of ≥2-grade improvement from baseline and a score of 'None' or 'Mild' on Investigator's Live Assessment (ILA) and Subject's Self-Assessment (SSA) at maximum frown. ILA: a validated 4-point photographic scale used to assess the severity and appearance of glabellar lines at maximum frown, where grade 0 = "None," grade 1 = "Mild," grade 2 = "Moderate," and grade 3 = "Severe." SSA: a 4-point categorical scale used to assess the appearance of glabellar lines at maximum frown, where grade 0 = "No wrinkles," grade 1 = "Mild wrinkles," grade 2 = "Moderate wrinkles," and grade 3 = "Severe wrinkles.

    Time frame: From baseline to each post-treatment visit except Week 4 (up to 55 Weeks)

  3. Percentage of participants responding to treatment as measured by a score of 'None' or 'Mild' on the ILA at maximum frown at each post treatment visit except Week 24.

    ILA: a validated 4-point photographic scale used to assess the severity and appearance of glabellar lines at maximum frown, where grade 0 = "None," grade 1 = "Mild," grade 2 = "Moderate," and grade 3 = "Severe."

    Time frame: From baseline to each post-treatment, except Week 24 (up to 55 Weeks)

  4. Percentage of participants responding to treatment as measured by a score of 'None' or 'Mild' on the SSA at maximum frown at each post treatment visit.

    SSA: a 4-point categorical scale used to assess the appearance of glabellar lines at maximum frown, where grade 0 = "No wrinkles," grade 1 = "Mild wrinkles," grade 2 = "Moderate wrinkles," and grade 3 = "Severe wrinkles.

    Time frame: From baseline to each post-treatment (up to 55 Weeks)

  5. Percentage of participants with ≥1-grade improvement on the ILA at maximum frown at each post treatment visit

    ILA: a validated 4-point photographic scale used to assess the severity and appearance of glabellar lines at maximum frown, where grade 0 = "None," grade 1 = "Mild," grade 2 = "Moderate," and grade 3 = "Severe."

    Time frame: From baseline to each post-treatment visit (up to 55 Weeks)

  6. Percentage of participants with ≥1-grade improvement on the SSA at maximum frown at each post treatment visit

    SSA: a 4-point categorical scale used to assess the appearance of glabellar lines at maximum frown, where grade 0 = "No wrinkles," grade 1 = "Mild wrinkles," grade 2 = "Moderate wrinkles," and grade 3 = "Severe wrinkles.

    Time frame: From baseline to each post-treatment visit (up to 55 Weeks)

  7. Percentage of participants with ≥1-grade improvement on the ILA at rest at each post treatment visit

    ILA: a validated 4-point photographic scale used to assess the severity and appearance of glabellar lines at maximum frown, where grade 0 = "None," grade 1 = "Mild," grade 2 = "Moderate," and grade 3 = "Severe."

    Time frame: From baseline to each post-treatment visit (up to 55 Weeks)

  8. Percentage of participants satisfied with their facial appearance after the treatment as measured by a score of 'Very Satisfied' or 'Satisfied' on Subject's Level of Satisfaction (SLS)

    SLS: a 4-point categorical scale used to assess satisfaction with the appearance of glabellar lines, where grade 0 = "Very satisfied," grade 1 = "Satisfied," grade 2 = "Dissatisfied," and grade 3 = "Very dissatisfied."

    Time frame: From baseline to each post-treatment visit (up to 55 Weeks)

  9. Percentage of participants with change from baseline in psychological function, as measured by Psychological Well-Being Scale on FACE-Q

    FACE-Q Psychological Function Scale: a validated 4-point categorical scale used to assess participants' psychological well-being. The scale consists of statements about how participants feel about themselves, with responses indicating the level of agreement on a 4-point scale ranging from "strongly disagree" to "strongly agree."

    Time frame: From baseline to each post-treatment visit (up to 55 Weeks)

  10. Time to onset of treatment response based on subject diary to evaluate the appearance of their lines

    Participants record in a diary whether they notice an improvement in the appearance of their glabellar lines, with responses captured as Yes/No.

    Time frame: At baseline and daily from Day 1 to Day 8 (Week 1)

  11. Time taken for a responder to re-exhibit their baseline severity grade on the ILA at maximum frown

    Responder is defined as having a score of 'None' or 'Mild' on the ILA. ILA: a validated 4-point photographic scale used to assess the severity and appearance of glabellar lines at maximum frown, where grade 0 = "None," grade 1 = "Mild," grade 2 = "Moderate," and grade 3 = "Severe."

    Time frame: At all timepoints post-injection (Day 1) until end of study (up 55 Weeks)

  12. Time taken for a responder to re-exhibit a severity grade of 'Moderate' or 'Severe' as measured by the ILA at maximum frown

    Responder is defined as having a score of 'None' or 'Mild' on the ILA. ILA: a validated 4-point photographic scale used to assess the severity and appearance of glabellar lines at maximum frown, where grade 0 = "None," grade 1 = "Mild," grade 2 = "Moderate," and grade 3 = "Severe."

    Time frame: At all timepoints post-injection (Day 1) until end of study (up to 55 Weeks)

  13. Percentage of participants experiencing treatment emergent adverse events (TEAEs) by severity and nature of TEAEs.

    An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAE is an AE for which the start date is on or after the date that the intervention began.

    Time frame: At all timepoints post-injection (Day 1) until end of study (up to 55 Weeks)

  14. Percentage of participants experiencing serious adverse events (SAEs) by nature of SAEs

    A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect, or is considered medically significant by the investigator.

    Time frame: At all timepoints post-injection (Day 1) until end of study (up to 55 Weeks)

  15. Percentage of participants experiencing Adverse Events (AEs) (or SAEs) leading to withdrawals, by severity and nature of these AEs.

    An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAE is an AE for which the start date is on or after the date that the intervention began.

    Time frame: At all timepoints post-injection (Day 1) until end of study (up to 55 Weeks)

  16. Percentage of participants experiencing Adverse Events of Special Interest (AESIs), severity and nature of these AESIs

    Adverse events of special interest (AESIs) are AEs that may not be serious but are of special importance to a particular drug or class of drugs.

    Time frame: At all timepoints post-injection (Day 1) until end of study (up to 55 Weeks)

  17. Percentage of participants with clinically significant changes from baseline in vital signs

    Clinically significant changes in vital signs will be reported. The clinical significance will be graded by the investigator.

    Time frame: At all timepoints post-injection (Day 1) until end of study (up to 55 Weeks)

  18. Percentage of participants with clinically significant change from baseline in facial and focused neurological/physical examination

    Clinically significant changes in facial examination and focused neurological/physical examinations will be reported. The clinical significance will be graded by the investigator.

    Time frame: At all timepoints post-injection (Day 1) until end of study (up to 55 Weeks)

  19. Percentage of participants with binding antibodies to corabotase

    Time frame: At screening, week 4, 12, 24, 36, 52

  20. Percentage of participants with neutralising antibodies to corabotase

    Time frame: At screening, week 4, 12, 24, 36, 52

07

Study locations

2 of 9 sites recruiting
  • The Third Affiliated Hospital of Sun Yat-sen University
    Guangzhou, Guangdong 510631, China
    Not yet recruiting
  • Xiangya School of Medicine at Central South University
    Changsha, Hunan 410008, China
    Not yet recruiting
  • Drum Tower Hospital, Affiliated Hospital of Nanjing University Medical School
    Nanjing, Jiangsu 210093, China
    Not yet recruiting
  • Wuxi People's Hospital
    Wuxi, Jiangsu 214028, China
    Recruiting
  • Huashan Hospital Affiliated to Fudan University
    Jing’an, Shanghai Muncipality 200040, China
    Not yet recruiting
  • West China Hospital of Sichuan University
    Chengdu, Sichuan 610093, China
    Not yet recruiting
  • Zhejiang Provincial People's Hospital
    Hangzhou, Zhejiang 310003, China
    Not yet recruiting
  • Peking university first hospital
    Beijing, 100034, China
    Recruiting
  • Peking Union Medical College Hospital (PUMCH)
    Beijing, 100730, China
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants

Time frame: Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and/or EU.

Access criteria: Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).

Data sharing details ↗ · www.ipsen.com

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07779252
Lead sponsor
Ipsen
Responsible party
Sponsor
First posted
Aug 21, 2026
Start date
Aug 25, 2026
Primary completion
Apr 10, 2028 (estimated)
Completion
Apr 10, 2028 (estimated)
Last update
Sep 14, 2026

Study contacts

Ipsen Recruitment Enquiries
Contact
clinical.trials@ipsen.com

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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