CORABOTASE for Glabellar (frown) lines

Stratification factors

• ILA severity
• gender

Inclusion criteria

• {"criterion_text":"- 1) Participant should be male or female, ≥18 years of age at the time of signing the informed consent.\n- 2) Moderate or severe (Grade 2 or 3) GL at MF at baseline, as assessed by the ILA using a validated 4-point photographic scale.\n- 3) Moderate or severe (Grade 2 or 3) GL at MF at baseline, as assessed by the SSA using a 4-point categorical scale.\n- 4) Are ‘dissatisfied’ or ‘very dissatisfied’ with their GLs at baseline, as assessed by the SLS score.\n- 5) For female participants: Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n- 6) Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n- 7) Participant has both the time and ability to complete the study and comply with study instructions.\n- 8) Does not reside in an institution by administrative or court order.\n- 9) 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

• {"criterion_text":"- 1) An active infection or other skin problems in the upper face including the GL area (e.g. acute acne lesions or ulcers).\n- 10) Use of medications that affect neuromuscular transmission (such as curare-like nondepolarising agents, lincosamides, polymyxins, anticholinesterases) within the past 30 days prior to baseline is 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.\n- 11) 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.\n- 12) 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.\n- 13) Any prior treatment with permanent fillers, lifting threads, autologous fat or permanent procedures in the upper face including the GL area.\n- 14) Administration of any nonpermanent injectables (such as hyaluronic acid, calcium hydroxylapatite, poly-L-lactic acid or polymethyl-methacrylate) for soft tissue augmentation therapy in the GL region within 12 months prior to baseline.\n- 15) Any prior facial treatment or aesthetic procedures to the upper face including photorejuvenation, vascular or pigment laser or microneedling within the 3 months prior to baseline.\n- 16) 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.\n- 17) 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.\n- 18) Any past surgery in the upper facial line area including GL.\n- 19) 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.\n- 2) A history of eyelid blepharoplasty or brow lift or any other upper facial surgery within the past 5 years.\n- 20) 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 half-life is unknown within 30 days prior to the start of the study (prior to baseline) and during the conduct of the study.\n- 21) Known positive for hepatitis B antigen, or hepatitis C virus antibody, or for human immunodeficiency virus or a diagnosis of acquired immunodeficiency syndrome.\n- 22) 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.\n- 23) An inability to substantially lessen GL as determined by the investigator.\n- 24) Known allergy or hypersensitivity to BoNT or any excipients of IPN10200.\n- 25) A history of chronic or recreational drug abuse as assessed by the investigator.\n- 26) 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.\n- 3) A history of facial nerve palsy.\n- 4) Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring or thick sebaceous skin.\n- 5) Closed-angle glaucoma or a predisposition to it (for Japan only).\n- 6) Any known medical condition that may put the participant at increased risk with regard to exposure to BoNT of any serotype (i.e. myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, etc.).\n- 7) Presence of any scars, piercings, or tattoos (including microblading 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.\n- 8) Administration of any BoNT (other than the study intervention) into any site of the body and for any indication from 9 months prior to the first study visit until the end of the study.\n- 9) Treatment with IPN10200 in any prior study."}

Primary endpoints

• {"endpoint_text":"- 1) For North America: Multi-component response as measured by an improvement of at least 2 grades from baseline and a score of ‘None’ or ‘Mild’ at Week 4 on the Investigator's Live Assessment (ILA) and Subject's self-Assessment (SSA) at Maximum Frown (MF).","definition_or_measurement_approach":"Multi-component response defined as an improvement of ≥2 grades from baseline and a score of 'None' or 'Mild' at Week 4 on both the Investigator's Live Assessment (ILA) and Subject's Self-Assessment (SSA) measured at Maximum Frown (MF)."}
• {"endpoint_text":"- 2) For EU and ROW: An improvement of at least 2 grades from baseline at Week 4 on the ILA at MF.","definition_or_measurement_approach":"Improvement defined as at least 2-grade improvement from baseline on the Investigator Live Assessment (ILA) at Maximum Frown (MF) at Week 4."}

Secondary endpoints

• {"endpoint_text":"- 1) DOUBLE BLIND PHASE: Response to treatment as measured by a score of ‘None’ or ‘Mild’ on the Investigator Live Assessment (ILA) at Maximum Frown (MF) at each post treatment visit (except at Week 4 (for EU and ROW) and Week 24).","definition_or_measurement_approach":"ILA score of 'None' or 'Mild' at MF at post-treatment visits (exceptions as stated)."}
• {"endpoint_text":"- 2) DOUBLE BLIND PHASE: Response to treatment as measured by a score of ‘None’ or ‘Mild’ on the Subject's Self Assessment (SSA) at MF at each post treatment visit (except Week 24).","definition_or_measurement_approach":"SSA score of 'None' or 'Mild' at MF at post-treatment visits (except Week 24)."}
• {"endpoint_text":"- 3) DOUBLE BLIND PHASE: Multi-component response as measured by a 2 grade improvement and a score of ‘None’ or ‘Mild’ on both the ILA and SSA at MF at each post treatment visit (except at Week 4 and Week 24 (for North America)).","definition_or_measurement_approach":"Combined criterion: ≥2-grade improvement plus 'None' or 'Mild' on both ILA and SSA at MF at visits (exceptions as stated)."}
• {"endpoint_text":"- 4) DOUBLE BLIND PHASE: 2-grade improvement on the ILA at MF at each post-treatment visit (except at Week 4 for EU and ROW).","definition_or_measurement_approach":"≥2-grade improvement on ILA at MF at post-treatment visits (exceptions as stated)."}
• {"endpoint_text":"- 5) DOUBLE BLIND PHASE: 2-grade improvement on the SSA at MF at each post-treatment visit.","definition_or_measurement_approach":"≥2-grade improvement on SSA at MF at post-treatment visits."}
• {"endpoint_text":"- 6) DOUBLE BLIND PHASE: 1-grade improvement on the ILA at MF at each post-treatment visit.","definition_or_measurement_approach":"≥1-grade improvement on ILA at MF at post-treatment visits."}
• {"endpoint_text":"- 7) DOUBLE BLIND PHASE: 1-grade improvement on the SSA at MF at each post-treatment visit.","definition_or_measurement_approach":"≥1-grade improvement on SSA at MF at post-treatment visits."}
• {"endpoint_text":"- 8) DOUBLE BLIND PHASE: 1-grade improvement on the ILA at rest at each post-treatment visit.","definition_or_measurement_approach":"≥1-grade improvement on ILA measured at rest at post-treatment visits."}
• {"endpoint_text":"- 9) DOUBLE BLIND PHASE: ‘Very Satisfied’ or ‘Satisfied’ answer on the SLS at each post treatment visit (except at Week 4 and Week 24 for all regions except United States)","definition_or_measurement_approach":"Participant satisfaction measured by SLS with responses 'Very Satisfied' or 'Satisfied' at visits (exceptions as stated)."}
• {"endpoint_text":"- 10) DOUBLE BLIND PHASE: Change from baseline in the ageing appearance VAS score of the FACE-Q scale at each post treatment visit.","definition_or_measurement_approach":"Change from baseline in FACE-Q ageing appearance VAS score at post-treatment visits."}
• {"endpoint_text":"- 11) DOUBLE BLIND PHASE: Response as measured by an improvement of at least 10 points from baseline on the Rasch Transformed Score of the FACE-Q Psychological Function Scale at all timepoints (except at Week 4 for EU).","definition_or_measurement_approach":"≥10-point improvement from baseline on Rasch-transformed FACE-Q Psychological Function Scale (exceptions as stated)."}
• {"endpoint_text":"- 12) DOUBLE BLIND PHASE: Time to onset of treatment response based on participant’s diary (timeframe Days 1 to 8).","definition_or_measurement_approach":"Participant diary reporting time to onset of response measured Days 1–8."}
• {"endpoint_text":"- 13) DOUBLE BLIND PHASE: The time taken for a responder to re-exhibit a severity grade of ‘Moderate’ or ‘Severe’ as measured by the ILA at MF following IMP administration. Note: Responder is defined as having a score of ‘None’ or ‘Mild’ on the ILA","definition_or_measurement_approach":"Time from response to recurrence to 'Moderate' or 'Severe' by ILA at MF; responder defined as 'None' or 'Mild' on ILA."}
• {"endpoint_text":"- 14) DOUBLE BLIND PHASE: Incidence, severity and nature of TEAEs, SAEs or AEs (or SAEs) leading to discontinuations and AESIs (throughout the study duration in the DB Phase).","definition_or_measurement_approach":"Safety outcomes: incidence, severity, and nature of TEAEs, SAEs, discontinuations due to AEs, and AESIs during DB phase."}
• {"endpoint_text":"- 15) DOUBLE BLIND PHASE: Clinically significant changes in vital signs, ECGs, facial and focused neurological/physical examination compared to baseline (throughout the study duration in the DB Phase).","definition_or_measurement_approach":"Clinical assessments for significant changes in vitals, ECGs, and focused neurological/physical facial exams vs baseline."}
• {"endpoint_text":"- 16) DOUBLE BLIND PHASE: Presence of IPN10200 antibodies and titres (binding and neutralising) at screening, end of W4, W12, W24, W36* and W52 (end of the DB Phase). *At Week 36 only if not eligible for retreatment before.","definition_or_measurement_approach":"Immunogenicity: measurement of binding and neutralising anti-IPN10200 antibodies at specified timepoints (screening, W4, W12, W24, W36*, W52)."}
• {"endpoint_text":"- 17) OPEN LABEL PHASE: Multi-component response as measured by a 2-grade improvement and a score of ‘None’ or ‘Mild’ on both the ILA and SSA at MF at each post-treatment visit within each cycle.","definition_or_measurement_approach":"Combined ≥2-grade improvement and 'None'/'Mild' on both ILA and SSA at MF at post-treatment visits in OL cycles."}
• {"endpoint_text":"- 18) OPEN LABEL PHASE: Response to treatment as measured by a score of ‘None’ or ‘Mild’ on the ILA at MF at each post-treatment visit within each cycle.","definition_or_measurement_approach":"ILA 'None' or 'Mild' at MF at post-treatment visits in OL cycles."}
• {"endpoint_text":"- 19) OPEN LABEL PHASE: Response to treatment as measured by a score of ‘None’ or ‘Mild’ on the SSA at MF at each post-treatment visit within each cycle.","definition_or_measurement_approach":"SSA 'None' or 'Mild' at MF at post-treatment visits in OL cycles."}
• {"endpoint_text":"- 20) OPEN LABEL PHASE: 2-grade improvement and a score of ‘None’ or ‘Mild’ on the ILA at MF at each post-treatment visit within each cycle.","definition_or_measurement_approach":"≥2-grade improvement plus 'None'/'Mild' on ILA at MF at visits in OL cycles."}
• {"endpoint_text":"- 21) OPEN LABEL PHASE: 2-grade improvement and a score of ‘None’ or ‘Mild’ on the SSA at MF at each post-treatment visit within each cycle.","definition_or_measurement_approach":"≥2-grade improvement plus 'None'/'Mild' on SSA at MF at visits in OL cycles."}
• {"endpoint_text":"- 22) OPEN LABEL PHASE: 1-grade improvement on the ILA at MF at each post-treatment visit.","definition_or_measurement_approach":"≥1-grade improvement on ILA at MF at post-treatment visits in OL phase."}
• {"endpoint_text":"- 23) OPEN LABEL PHASE: 1-grade improvement on the SSA at MF at each post-treatment visit.","definition_or_measurement_approach":"≥1-grade improvement on SSA at MF at post-treatment visits in OL phase."}
• {"endpoint_text":"- 24) OPEN LABEL PHASE: 1-grade improvement on the ILA at rest at each post-treatment visit.","definition_or_measurement_approach":"≥1-grade improvement on ILA at rest at post-treatment visits in OL phase."}
• {"endpoint_text":"- 25) OPEN LABEL PHASE: ‘Very Satisfied’ or ‘Satisfied’ answer on the SLS at each post-treatment visit within each cycle.","definition_or_measurement_approach":"Participant satisfaction by SLS ('Very Satisfied' or 'Satisfied') at OL visits."}
• {"endpoint_text":"- 26) OPEN LABEL PHASE: Change from baseline in the ageing appearance VAS score of the FACE-Q Scale at each post treatment visit within each cycle.","definition_or_measurement_approach":"Change from baseline in FACE-Q ageing appearance VAS at OL visits."}
• {"endpoint_text":"- 27) OPEN LABEL PHASE: Response as measured by an improvement of at least 10 points from baseline on the Rasch Transformed Score of the FACE-Q Psychological Function Scale at each post treatment visit within each cycle.","definition_or_measurement_approach":"≥10-point improvement from baseline on Rasch-transformed FACE-Q Psychological Function Scale at OL visits."}
• {"endpoint_text":"- 28) OPEN LABEL PHASE: The time between two consecutive injections.","definition_or_measurement_approach":"Interval measured between consecutive injections."}
• {"endpoint_text":"- 29) OPEN LABEL PHASE: Incidence, severity and nature of the TEAEs, SAEs, AEs (or SAEs) leading to discontinuations and AESIs (throughout the study duration in the OL Phase).","definition_or_measurement_approach":"Safety outcomes in OL phase: incidence, severity, nature of TEAEs/SAEs/AEs leading to discontinuation and AESIs."}
• {"endpoint_text":"- 30) OPEN LABEL PHASE: Clinically significant changes in vital signs, facial and focused neurological/physical examination compared to baseline (throughout the study duration in the OL Phase).","definition_or_measurement_approach":"Clinical safety assessments vs baseline in OL phase (vitals, focused neurological/physical facial exams)."}
• {"endpoint_text":"- 31) OPEN LABEL PHASE: Presence of IPN10200 antibodies and titres (binding and neutralising) at screening, end of W4, W12, W24, W36*, W52 of each cycle and at EOS. *At Week 36 only if not eligible for retreatment before.","definition_or_measurement_approach":"Immunogenicity measurements (binding and neutralising antibodies) at specified timepoints per OL cycle and at EOS."}

Methods

• Germany: Recruitment materials including Facebook ads, Web Banner Ad, Print Ad, Study Poster, Poster Male, Flyer, Flyer Male, Brochure, Radio Script (documents titled K2_DE_Recruitment Material_*, K1_DE_Recruitment Procedure).
• France: Bilingual recruitment procedure and recruitment materials (K1_FR_Recruitment Procedure_Bilingual and related K2_FR materials).
• Site-level recruitment via study centre contact details (listed trial sites with contact emails/phone numbers).

France

Earliest CTIS Part Ii Submission Date

27-04-2026

Latest Decision Or Authorization Date

07-05-2026

Processing Time Days

10

Number Of Sites

3

Number Of Participants

40

Germany

Earliest CTIS Part Ii Submission Date

11-05-2026

Latest Decision Or Authorization Date

13-05-2026

Processing Time Days

2

Number Of Sites

9

Number Of Participants

190

Primary sponsor

Full Name

Ipsen Innovation

Organisation Type

Pharmaceutical company

Country Of Registered Address

France

Contract research organisations

Name

Icon Clinical Research Limited

Responsibilities

Sponsor duties list includes code 15 with value 'CRO' and other sponsorDuties codes as recorded in CTIS (see third_party duties_or_roles field).

Third parties

• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"[{\"id\":930394,\"code\":\"1\"},{\"id\":930395,\"code\":\"12\"},{\"id\":930396,\"code\":\"13\"},{\"id\":930397,\"code\":\"15\",\"value\":\"CRO\"},{\"id\":930398,\"code\":\"2\"},{\"id\":930399,\"code\":\"4\"},{\"id\":930400,\"code\":\"5\"},{\"id\":930401,\"code\":\"8\"}]","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"S-Clinica","duties_or_roles":"[{\"id\":930402,\"code\":\"3\"}]","organisation_type":"Pharmaceutical company"}
• {"country":"Spain","full_name":"Kymos S.L.","duties_or_roles":"[{\"id\":930403,\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"[{\"id\":930404,\"code\":\"15\",\"value\":\"Packaging, storage, distribution, return and destruction\"}]","organisation_type":"Pharmaceutical company"}