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Active, not recruitingNCT04821089LANTICUpdated Oct 6, 2026

A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Moderate to Severe Upper Facial Lines

A Phase 1/2 interventional study of Corabotase and IPN10200 Placebo in Moderate to Severe Upper Facial Lines, sponsored by Ipsen. Active, not recruiting at 10 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by Ipsen · Phase 1/2, Interventional, and Treatment

Updated Oct 6, 2026Primary completion movedGo to Updates ↓
Phase
Phase 1/2
Study type
Interventional
Enrollment
727
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The purpose of this study is to assess the safety and efficacy profile of increasing doses of Corabotase (also known as IPN10200) in comparison to placebo, with the aim to discover the doses(s) that offer the best efficacy/safety profile when used for the treatment of moderate to severe Upper Facial Lines.

This study will be conducted in three stages. The full study (including all stages) will have a maximum 727 participants.

Stage 1 (phase Ib \& II)

  • Step 1 (Phase Ib): a dose-escalation first-in-human step in participants with moderate to severe Glabellar Lines (GL)
  • Step 2 (Phase II): dose ranging step in participants with moderate to severe GL as compared with Dysport
  • Step 3 (Phase II): dose finding step in participants with moderate to severe GL as compared with Dysport, followed by an open label (OL) phase for the highest dose cohort to assess the long-term safety and efficacy of Corabotase. In the OL phase, participants may receive repeat administrations of Corabotase for up to three additional cycles (up to four treatment cycles in total during the study).

Stage 2 (phase II) - An evaluation of efficacy and safety of Corabotase in one of the following regions: GL + forehead lines (FHL), forehead lines (FHL) or lateral canthal lines (LCL)

Stage 3 (phase II)

- A safety and efficacy evaluation of Corabotase in all three regions (GL, FHL and LCL)

02

Conditions studied

  • Moderate to Severe Upper Facial Lines
03

In context

Lead sponsor

Ipsen is the lead sponsor of 282 studies on the registry; 16 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
  2. Moderate or severe (Grade 2 or 3) GL (Stage 1) at maximum contraction at Baseline, as assessed by the ILA using a validated 4-point photographic scale.
  3. Moderate or severe (Grade 2 or 3) GL (Stage 1) at maximum contraction at Baseline, as assessed by the SSA using a validated 4-point categorical scale.
  4. Moderate or severe (Grade 2 or 3) FHL (Stage 2) at maximum contraction and moderate to severe GL at maximum contraction at Baseline or moderate to severe (Grade 2 or 3) LCL (Stage 2) at maximum contraction (Stage as assessed by the ILA using a 4-point photographic scale).
  5. Moderate or severe (Grade 2 or 3) FHL (Stage 3) at maximum contraction and moderate to severe GL at maximum contraction at Baseline and moderate to severe (Grade 2 or 3) LCL (Stage 3) at maximum contraction (Stage as assessed by the ILA using a 4-point photographic scale).
  6. Moderate or severe (Grade 2 or 3) FHL (Stage 2) at maximum contraction and moderate to severe GL maximum contraction at Baseline or moderate to severe (Grade 2 or 3) LCL (Stage 2) at maximum contraction as assessed by the SSA using a 4-point photographic scale.
  7. Moderate or severe (Grade 2 or 3) FHL (Stage 3) at maximum contraction and moderate to severe GL maximum contraction at Baseline and moderate to severe (Grade 2 or 3) LCL (Stage 3) at maximum contraction, as assessed by the SSA using a 4-point photographic scale.
  8. Dissatisfied or very dissatisfied (Grade 2 or 3) with their lines (Stages 1 to 3) at Baseline, as assessed by the SLS.
  9. Male and female participants (only female for Stage 1/Step 1). Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
  10. Capable of giving signed informed consent includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
  11. Participant has both the time and the ability to complete the study and comply with study instructions.
  12. Does not reside in an institution by administrative or court order.
  13. 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:

  1. An active infection or other skin problems in the upper face including the GL, FHL, and LCL area (e.g. acute acne lesions or ulcers).
  2. A history of eyelid blepharoplasty or brow lift within the past 5 years
  3. A history of facial nerve palsy.
  4. Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin.
  5. 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.)
  6. Has COVID-19 illness or a known positive SARS-CoV-2 test (Stage 1), or the presence of any other condition (e.g. neuromuscular disorder or other disorder that could interfere with neuromuscular function)
  7. Previous treatment with any BoNT serotype for Stage 1 / Step 1 or any recent treatment (within the past 9 months prior to baseline) with any BoNT serotype for Stage 1 / Step 2, Stage 1/Step 3, Stages 2 and 3. Participants treated in earlier Stages/Steps of the study must not be included in any later Stages/Steps.
  8. Any prior treatment with permanent fillers in the upper face including the GL, FHL and LCL area.
  9. Any prior treatment with long lasting dermal fillers or any permanent procedures in the upper face inclusion the GL area within the past 3 years and/or skin abrasions/resurfacing (whatever the interventional technic used) within the past 5 years, or photo rejuvenation or skin/vascular laser intervention within the 12 months prior to Baseline.
  10. Any planned facial cosmetic surgery during the study.
  11. 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.
  12. Use of medications that affect neuromuscular transmission, such as curare-like non depolarising agents, lincosamides, polymyxins, anticholinesterases, aminoglycoside antibiotics and systemic retinoids, 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 longer-acting medications. Topical use of for example aminoglycoside medications or topical retinoids on the face apart from the area of injection would be acceptable.
  13. Use of any experimental device within 30 days 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 halflife is unknown within 30 days prior to the start of the study (prior to Baseline) and during the conduct of the study.
  14. Known positive for hepatitis B antigen, or hepatitis C virus antibody, or for human immunodeficiency virus (HIV) or a diagnosis of acquired immunodeficiency syndrome.
  15. 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
  16. An inability to substantially lessen GL and/or horizontal forehead rhytids even by physically spreading them apart as determined by the investigator.
  17. Known allergy or hypersensitivity to BoNT or any excipients of IPN10200 or Dusport/Azzalure, or allergy to cow's milk protein.
  18. A history of drug or alcohol abuse
  19. Pregnant women, nursing women, premenopausal women or women of childbearing potential not willing to practice a highly effective form of contraception method
  20. Male participants who are not vasectomized and who have female partners of childbearing potential and are not willing to use condoms with spermicide throughout study participation.
  21. 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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
727 participants (estimated)

Study arms

  • Experimental
    Corabotase group

    Stage 1/Step 1: Several cohorts of participants will be randomized in a ratio of 3:1 (Corabotase:placebo)in a dose-escalation manner. The decision to escalate to the next dose for each cohort will be based on Data Monitoring Committee (DMC) recommendation. Stage 1/Step 2: parallel dose-ranging manner Stage 1/Step 3: each cohort will include three treatment groups randomised in a ratio of 4:1:1 (Corabotase: placebo:dysport) The decision to escalate to the next dose for each cohort will be based on DMC recommendation . Stage 2: the dose(s) chosen for administration in each region of the face will be selected on the basis of the intermediate analyses of Stage 1/Step 3. Participants will be randomised for each group in a ratio of 4:4:1 (Corabotase:Corabotase:placebo). Stage 3: total dose for each region defined in Stages 1 and 2. Participants will be randomised for each group in a ratio of 3:1.

    Biological: Corabotase

  • Placebo comparator
    Placebo group

    Stage 1/Step 1: Several cohorts of participants will be randomized in a ratio of 3:1 in a dose-escalation manner. The decision to escalate to the next dose for each cohort will be based on Data Monitoring Committee (DMC) recommendation. Stage 1/Step 2: parallel dose-ranging manner Stage 1/Step 3: each cohort will include three treatment groups randomised in a ratio of 4:1:1 (Corabotase:Corabotase: placebo) The decision to escalate to the next dose for each cohort will be based on DMC recommendation. Stage 2: the dose(s) chosen for administration in each region of the face will be selected on the basis of the intermediate analyses of Stage 1/Step 3. Participants will be randomised for each group in a ratio of 4:4:1 (Corabotase:Corabotase:placebo). Stage 3: total dose for each region defined in Stages 1 and 2. Participants will be randomised for each group in a ratio of 3:1.(Corabotase:placebo)

    Biological: IPN10200 Placebo

  • Active comparator
    Dysport group (stage 1 / step 2 and 3 only)

    Biological: Dysport

Interventions

  • BiologicalCorabotase

    Stage 1: Several different doses will be administrated in a dose-escalation manner. One single injection will be injected locally into several sites across the glabellar region. Stage 2: One single injection will be injected locally into several sites across the glabellar, forehead and lateral Canthal regions. Stage 3: One single injection will be injected locally into several sites across the upper facial area.

  • BiologicalIPN10200 Placebo

    Stage 1: One single injection of study intervention will be injected locally into several sites across the glabellar region. Stage 2: One single injection will be injected locally into several sites across the glabellar, forehead and lateral Canthal regions. Stage 3: One single injection will be injected locally into several sites across the upper facial area.

  • BiologicalDysport

    Single administration of study intervention in stage 1 / step 2 and 3 only

06

What researchers measure

Primary outcomes

  1. Incidence of treatment emergent adverse events (TEAEs) at each dose

    At Stage 1/Step 1, Stage 3

    Time frame: From the baseline to the end of the study (9 months)

  2. Incidence of serious adverse events (SAEs) at each dose

    At Stage 1/Step 1, Stage 3

    Time frame: From the baseline to the end of the study (9 months)

  3. Incidence of Adverse Events (AEs) (or SAEs) leading to withdrawals and Adverse Events of Special Interest (AESIs)

    At Stage 1/Step 1, Stage 3

    Time frame: From the baseline to the end of the study (9 months)

  4. Response to treatment at Stage 2 for the FHL group

    Measured by the composite response of ≥ 2-grade improvement on Investigator's Live Assessment (ILA) and subject's self-assessment (SSA) at maximum contraction on the forehead lines: ILA: a validated 4-point photographic scale to assess the severity and appearance of the Forehead Lines (FHL) at maximum frown and at rest where 0 is "none" and 3 is "severe" SSA: a validated 4-point categorical scale to assess the appearance of their FHLs at maximum frown where 0 is "no wrinkles" and 3 is "severe wrinkles"

    Time frame: At Week 4

  5. Response to treatment at Stage 2 for the glabellar lines (GL)+ FHL group

    Measured by the composite response of ≥ 2-grade improvement on ILA and SSA at maximum contraction on the forehead lines (FHL) area: ILA: a validated 4-point photographic scale to assess the severity and appearance of the GLs and FHLs at maximum frown and at rest where 0 is "none" and 3 is "severe" SSA: a validated 4-point categorical scale to assess the appearance of their GLs and FHLs at maximum frown where 0 is "no wrinkles" and 3 is "severe wrinkles"

    Time frame: At Week 4

  6. Response to treatment at Stage 2 for the LCL group

    Measured by the composite response of ≥ 2-grade improvement ILA and SSA at maximum contraction on both sides of the lateral canthal lines (LCL) area: ILA: a validated 4-point photographic scale to assess the severity and appearance of the LCLs at maximum frown and at rest where 0 is "none" and 3 is "severe" SSA: a validated 4-point categorical scale to assess the appearance of their LCLs at maximum frown where 0 is "no wrinkles" and 3 is "severe wrinkles"

    Time frame: At Week 4

  7. Percentage of Participants With Clinically Significant Changes from baseline in Vital Signs

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

    Time frame: From the baseline to the end of the study (6 years, 5 months)

  8. Percentage of participants with clinically significant Change from baseline in 12-lead Electrocardiogram (ECG) readings

    Double Blind phase.

    Time frame: From the baseline to the end of the study (6 years, 5 months)

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

    Double Blind phase. 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: From the baseline to the end of the study (6 years, 5 months)

Secondary outcomes

  1. Percentage of participants response to treatment.

    For all stages. Measured by the composite response of ≥ 2-grade improvement on ILA and SSA for each concerned facial area in each respective stage (GL/LCL/FHL) ILA: a validated 4-point photographic scale to assess the severity and appearance of the GLs/LCLs/FHLs in each respective stage at maximum frown and at rest where 0 is "no lines are noticeable" and 3 is "lines are extremely pronounced" SSA: a validated 4-point categorical scale to assess the appearance of their GLs/LCLs/FHLs in each respective stage at maximum frown where 0 is "no wrinkles" and 3 is "severe wrinkles"

    Time frame: From the baseline to the end of the study (up to 6 years, 5 months)

  2. Percentage of participants response to treatment as measured by the reduction of ≥1 grade on the ILA at maximum contraction for each concerned facial area

    For all stages.

    Time frame: From the baseline to the end of the study (up to 6 years, 5 months)

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

    For all stages. 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: From the baseline to the end of the study (up to 6 years, 5 months)

  4. Percentage of participants response to treatment as achieved by a score of "none" or "mild" as measured by the ILA at rest on each facial area

    For all stages

    Time frame: From the baseline to the end of the study (up to 6 years, 5 months)

  5. Percentage of participants response to treatment as measured by the reduction of ≥1 grade on the SSA at maximum contraction for each concerned facial area

    For all stages.

    Time frame: From the baseline to the end of the study (up to 6 years, 5 months)

  6. Percentage of participants response to treatment as achieved by a score of "none" or "mild" as measured by the SSA at maximum contraction for each concerned facial area.

    Stage 2 and Stage 3.

    Time frame: From the baseline to the end of the study (up to 6 years, 5 months)

  7. Duration of treatment response based on ILA and SSA at maximum contraction for each concerned facial area

    For all stages.

    Time frame: From the baseline to the end of the study (up to 6 years, 5 months)

  8. Response to treatment as achieved by a score of "very satisfied" or "satisfied" on the Subject Level of Satisfaction (SLS)

    Time frame: From the baseline to the end of the study (9 months)

  9. Time to onset of treatment response based on subject diary cards to evaluate the appearance of their lines for each concerned facial area

    For all stages.

    Time frame: From the baseline to the end of the study (up to 6 years, 5 months)

  10. Satisfaction with facial appearance, measured by Facial Appearance Overall scale score on the Face-Q satisfaction scale

    Stage 3. Face Q is a participant-reported outcome instrument to evaluate the experience and outcomes of aesthetic facial procedures from the participant's perspective. The Face Q instrument is composed of over 40 scales, covering four domains (Satisfaction with Facial Appearance, Health Related Quality of Life, Adverse Effects, and Process of Care).

    Time frame: From the baseline to the end of the study (up to 6 years, 5 months)

  11. Satisfaction with facial appearance, measured by FACE-Q Short Form Facial Appearance scale score.

    Stage 3. The FACE-Q Short Form Facial Appearance scale is a participant-reported outcome instrument. It asks how dissatisfied or satisfied the participant is with their upper facial lines (UFL) (GL+FHL+LCL). The scale ranges from very dissatisfied to very satisfied.

    Time frame: From the baseline to the end of the study (6 years, 5 months)

  12. Incidence, severity and nature of treatment emergent adverse events (TEAEs)

    All stages (except Stage 1/Step 1)

    Time frame: From baseline to the end of the study (up to 6 years, 5 months)

  13. Incidence, severity and nature of serious adverse events (SAEs)

    All stages (except Stage 1/Step 1)

    Time frame: From baseline to the end of the study (up to 6 years, 5 months)

  14. Incidence, severity and nature of Adverse Events (AEs) (or SAEs) leading to withdrawals and Adverse Events of Special Interest (AESIs)

    All stages (except Stage 1/Step 1)

    Time frame: From baseline to the end of the study (up to 6 years, 5 months)

  15. Percentage of Participants With Clinically Significant Changes from baseline in Vital Signs

    All stages (except Stage 1/Step 1). Clinically significant changes in vital signs will be reported. The clinical significance will be graded by the investigator.

    Time frame: From baseline to the end of the study (6 years, 5 months)

  16. Time between two consecutive injections

    Stage 1/Step 3 .

    Time frame: From baseline to the end of the study (up to 6 years, 5 months)

  17. Percentage of participants with binding antibodies to IPN10200

    Stage 1/Step 2, Stage 1/Step 3, Stage 2, and Stage 3

    Time frame: At Week 4 , Week 24 and Week 36

  18. Percentage of participants with neutralising antibodies to IPN10200

    Stage 1/Step 2, Stage 1/Step 3, Stage 2, and Stage 3

    Time frame: At Week 4 , Week 24 and Week 36

  19. Percentage of participants with binding antibodies to BontA

    Stage 1/Step 2, Stage 1/Step 3, Stage 2, and Stage 3

    Time frame: At Week 4 , Week 24 and Week 36

  20. Percentage of participants with neutralising antibodies to BontA

    Stage 1/Step 2, Stage 1/Step 3, Stage 2, and Stage 3

    Time frame: At Week 4 , Week 24 and Week 36

07

Study locations

10 sites
  • MEDITI - Clinique Del Mar
    Antibes, France
  • Aimed S.A.S
    Lyon, France
  • Clinique de Chirurgie Esthétique Iéna
    Paris, France
  • Interdisciplinary Study Association
    Kassel, State of Berlin, Germany
  • CRS Clinical Research Services Berlin GMBH
    Berlin, 13353, Germany
  • Interdisciplinary Study Association
    Berlin, Germany
  • ROSENPARK RESEARCH GmbH
    Darmstadt, Germany
  • Privatpraxis Dr. Hilton & Partner
    Düsseldorf, Germany
  • Fachbereich Chemie Institut für Biologie und Molekularbiologie Studiengang Kosmetikwissenschaft
    Hamburg, Germany
  • Dermatologische Gemeinschaftspraxis Blankenfelde-Mahlow
    Mahlow, Germany
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.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Primary completion
Aug 31, 2026→Aug 19, 2027
Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    Primary completion Aug 31, 2026→Aug 19, 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04821089
Lead sponsor
Ipsen
Responsible party
Sponsor
First posted
Mar 29, 2021
Start date
Apr 6, 2021
Primary completion
Aug 19, 2027 (estimated)
Completion
Aug 19, 2027 (estimated)
Last update
Oct 6, 2026

Study contacts

Ipsen Medical Director
study director · Ipsen

Oversight

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

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