A Study to Assess the Effectiveness and Safety of IPN10200 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 Corabotase (also known as IPN10200) compared to placebo in the improvement of the appearance of moderate to severe glabellar lines in adult participants. 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 or placebo (the study drug). 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 IPN10200 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, 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 55 weeks. Participants may withdraw consent to participate at any time.

Key facts

Study ID

NCT07427797

Run by

Ipsen

People needed

300

Starts

2026-02-27

Expected to finish

2027-07-15

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 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.
• 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 the 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.
• 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.).
• Administration of any BoNT (other than the study intervention on baseline visit) 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.
• Participants who have received IPN10200 in a previous 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 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.

Where it is running

• Skin Wellness Dermatology - Homewood — Birmingham, Alabama, United States (enrolling)
• Advanced Research Associates — Glendale, Arizona, United States (enrolling)
• Dermatology and Laser Surgery Center — Houston, Texas, United States (enrolling)
• Pflugerville Dermatology Clinical Research Center, Inc. d/b/a Austin Institute for Clinical Research — Pflugerville, Texas, United States (enrolling)
• SkinDC — Arlington, Virginia, United States (enrolling)
• Carruthers and Humphrey Cosmetic Medicine — Vancouver, British Columbia, Canada (enrolling)
• Institute of Cosmetic and Laser Surgery — Oakville, Ontario, Canada (enrolling)
• Sweat clinics of canada — Toronto, Ontario, Canada (enrolling)
• Investigate MD, LLC — Scottsdale, Arizona, United States (enrolling)
• Ablon Skin Institute and Research Center — Manhattan Beach, California, United States (enrolling)
• Keith A. Marcus, MD Inc — Redondo Beach, California, United States (enrolling)
• Ava T. Shamban, M.D., Inc. — Santa Monica, California, United States (enrolling)
• Art of Skin MD — Solana Beach, California, United States (enrolling)
• Pacific Clinical Innovations Inc. — Vista, California, United States (enrolling)
• Skin Research Institute — Coral Gables, Florida, United States (enrolling)
• ICON Dermatology and Aesthetics — Bethesda, Maryland, United States (enrolling)
• Westlake Dermatology & Cosmetic Surgery - Westlake — Austin, Texas, United States (enrolling)
• Avacare — Scottsdale, Arizona, United States
• Clinical Research Center of the Carolinas — Charleston, South Carolina, United States
• Bertucci MedSpa — Woodbridge, Ontario, Canada
• Centre de Recherche Dermatologique de Quebec — Québec, Quebec, Canada
• West Dermatology — San Diego, California, United States
• Pacific Dermaesthetics Inc. — Vancouver, British Columbia, Canada

Full record on ClinicalTrials.gov

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