Moderate to Severe Glabellar LinesPhase 3LAURITE 3NCT07779252
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 study testing Corabotase in people with Moderate to Severe Glabellar Lines, run by Ipsen at 9 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to Severe Glabellar Lines
- What is being tested?
- Corabotase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 9 sitesChina
- Study dates
- 25 Aug 2026to 10 Apr 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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: Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Capable of giving signed informed consent 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.
Who cannot join
- 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.).
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- 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 washout period 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 hepatitis B antigen, hepatitis C virus antibody or for human immunodeficiency virus 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 hypersensitivity to BoNT or any excipients 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ipsen Recruitment Enquiries contact
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
Peking university first hospital
Beijing, 100034
- Not yet recruiting
Peking Union Medical College Hospital (PUMCH)
Beijing, 100730
- Not yet recruiting
Xiangya School of Medicine at Central South University
Changsha, Hunan, 410008
- Not yet recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610093
- Not yet recruiting
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510631
- Not yet recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310003
- Not yet recruiting
Huashan Hospital Affiliated to Fudan University
Jing’an, Shanghai Muncipality, 200040
- Not yet recruiting
Drum Tower Hospital, Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210093
- Recruiting
Wuxi People's Hospital
Wuxi, Jiangsu, 214028
About this study
Official title: A Phase III, Multicentre, Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of IPN10200 in the Improvement of the Appearance of Moderate To Severe Glabellar Lines in Adult Chinese Participants
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:
Read more
- 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.
- Conditions
- Moderate to Severe Glabellar Lines
- Being tested
- Corabotase, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorabotaseBiological
Also called IPN10200
A single vial of lyophilised powder for solution for injection will be injected locally into several sites across the glabellar region.
PlaceboBiological
A single vial of lyophilised powder for solution, containing excipients without active substance, will be injected locally into several sites across the glabellar region.
| Study group | Role | What they receive |
|---|---|---|
| Corabotase group | Experimental | Participants will receive corabotase through injections into the selected muscles on Day 1. Receives: Biological: Corabotase |
| Placebo group | Placebo comparator | Participants will receive placebo through injections into the selected muscles on Day 1. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Week 4
Secondary outcomes (20)
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."
Measured: At Week 24
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.
Measured: From baseline to each post-treatment visit except Week 4 (up to 55 Weeks)
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."
Measured: From baseline to each post-treatment, except Week 24 (up to 55 Weeks)
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.
Measured: From baseline to each post-treatment (up to 55 Weeks)
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."
Measured: From baseline to each post-treatment visit (up to 55 Weeks)
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.
Measured: From baseline to each post-treatment visit (up to 55 Weeks)
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."
Measured: From baseline to each post-treatment visit (up to 55 Weeks)
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."
Measured: From baseline to each post-treatment visit (up to 55 Weeks)
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."
Measured: From baseline to each post-treatment visit (up to 55 Weeks)
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.
Measured: At baseline and daily from Day 1 to Day 8 (Week 1)
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."
Measured: At all timepoints post-injection (Day 1) until end of study (up 55 Weeks)
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."
Measured: At all timepoints post-injection (Day 1) until end of study (up to 55 Weeks)
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.
Measured: At all timepoints post-injection (Day 1) until end of study (up to 55 Weeks)
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.
Measured: At all timepoints post-injection (Day 1) until end of study (up to 55 Weeks)
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.
Measured: At all timepoints post-injection (Day 1) until end of study (up to 55 Weeks)
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.
Measured: At all timepoints post-injection (Day 1) until end of study (up to 55 Weeks)
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.
Measured: At all timepoints post-injection (Day 1) until end of study (up to 55 Weeks)
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.
Measured: At all timepoints post-injection (Day 1) until end of study (up to 55 Weeks)
Percentage of participants with binding antibodies to corabotase
Measured: At screening, week 4, 12, 24, 36, 52
Percentage of participants with neutralising antibodies to corabotase
Measured: At screening, week 4, 12, 24, 36, 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start25 Aug 2026
- Primary completion10 Apr 2028 (estimated)
- Study completion10 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Glabellar LinesStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07779252
- Sponsor's protocol ID
- CLIN-10200-460
- Acronym
- LAURITE 3
- Status last verified
- Sep 2026
- First submitted
- 19 Aug 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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