A Study to Assess the Effectiveness and Safety of IPN10200 Over Time in Adults With Moderate to Severe Wrinkle-like Lines Between the Eyebrows

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Moderate to Severe Glabellar Lines

In brief

The purpose of this study is to assess the effectiveness and safety of a single dose of Corabotase (also known as IPN10200) compared to placebo (double-blind phase) and how well and safely repeat doses of Corabotase work over time (open-label phase) in adult 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. All participants in the double-blind phase will receive Corabotase or placebo during the first treatment cycle. De novo participants in the open-label phase will receive IPN10200 during the first treatment cycle. Some participants may receive additional treatment cycles with Corabotase depending on their eligibility. 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 where participants may receive up to 4 treatment cycles. In the double-blind phase, participants receive a single treatment of Corabotase or placebo. In the open-label phase (rollover participants from double-blind), eligible participants may receive additional cycles of Corabotase . In the open-label phase (de novo participants), participants will receive Corabotase in the first cycle and eligible participants may receive additional cycles of Corabotase. Requires multiple visits during the first month followed by 1 visit every month. * A follow-up period (24 weeks) after the last injection where participants' health will be monitored. Participants will undergo health measurements and observation, including blood sampling, physical examinations, clinical evaluations and electrocardiograms (ECG: recording of the electrical activity of heart). They will also be asked to fill in questionnaires and keep a diary. Each participant will be in this study for up to 107 weeks. Participants may withdraw consent to participate at any time.

Key facts

Study ID

NCT07435428

Run by

Ipsen

People needed

1300

Starts

2026-02-18

Expected to finish

2028-10-01

Last updated by the study team

2026-07-28

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant should be male or female, ≥18 years of age at the time of signing the informed consent.
• 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.
• Are 'dissatisfied' or 'very dissatisfied' with their GLs at baseline, as assessed by the SLS score.
• For 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 ability to complete the study and comply with study instructions.
• Does not reside in an institution by administrative or court order.
• 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.

You may not qualify if…

• 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.
• Closed-angle glaucoma or a predisposition to it (for Japan only).
• 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.).
• 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.
• 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.
• Treatment with IPN10200 in any prior study.
• 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.
• 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 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.
• 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.
• 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 upper facial line 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 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.
• Known positive for hepatitis B antigen, or 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.

Where it is running

• Rejuva Center at Williams — Latham, New York, United States (enrolling)
• Dr. Z. Paul Lorenc MD, Office Of — New York, New York, United States (enrolling)
• StracSkin — Portsmouth, New Hampshire, United States (enrolling)
• Skin and Beauty Center — Pasadena, California, United States (enrolling)
• The Center for Dermatology, Cosmetic & Laser Surgery — Mount Kisco, New York, United States (enrolling)
• Luxurgery — New York, New York, United States (enrolling)
• Clinical Testing of Beverly Hills — Los Angeles, California, United States (enrolling)
• Skin Specialists PC dba Schlessinger MD — Omaha, Nebraska, United States (enrolling)
• Skin and Cancer Associates (SCA) and the Center for Cosmetic Enhancement (CCE) - Aventura — Aventura, Florida, United States (enrolling)
• Weinkle Dermatology — Bradenton, Florida, United States (enrolling)
• Eye Research Foundation — Newport Beach, California, United States (enrolling)
• Miami Dermatology & Laser Research — Miami, Florida, United States (enrolling)
• Kavali Plastic Surgery and Skin Renewal Center — Atlanta, Georgia, United States (enrolling)
• DeNova Research — Chicago, Illinois, United States (enrolling)
• Chicago Cosmetic and Dermatologic Research — Chicago, Illinois, United States (enrolling)
• DMR Research, PLLC — Westport, Connecticut, United States (enrolling)
• LASSI - Laser and Skin Surgery Center of Indiana — Indianapolis, Indiana, United States (enrolling)
• Steve Yoelin MD Medical Associates Inc — Newport Beach, California, United States (enrolling)
• DelRicht Research — New Orleans, Louisiana, United States (enrolling)
• Etre, Cosmetic Dermatology and Laser Center — New Orleans, Louisiana, United States (enrolling)
• Maryland Laser, Skin, & Vein Institute, LLC (MDLSV) — Hunt Valley, Maryland, United States (enrolling)
• Lawrence J. Green, MD. LLC — Rockville, Maryland, United States (enrolling)
• SkinCare Physicians — Chestnut Hill, Massachusetts, United States (enrolling)
• Michigan Center for Research Company — Clarkston, Michigan, United States (enrolling)
• Skin Search Of Rochester, Inc. — Rochester, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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