Recruiting
Phase 3

IPN10200

Sponsor:

Ipsen

Code:

NCT07435428

Conditions

Moderate to Severe Glabellar Lines

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Corabotase

Placebo

Study Details

Brief summary:

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.

Conditions

Moderate to Severe Glabellar Lines

Study ID

NCT07435428

Start date

Feb 18, 2026

Status verified date

Sep, 2026

Completion date

Oct 1, 2028

Anticipated

Primary completion date

Dec 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Design

Enrollment

1300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Corabotase group

Participants will receive Corabotase via injection into the selected muscles on Day 1 of the double-blind (DB) phase.

Participants who are new to treatment (the de novo phase) will receive Corabotase via injections into the selected muscles during the first and subsequent treatment cycles.

placebo comparator: Placebo group

Participants will receive placebo via injection into the selected muscles on Day 1 of the DB phase.

Interventions

Corabotase

A single vial of lyophilised powder for solution for injection will be injected locally into several sites across the glabellar region.

Placebo

A single vial of lyophilised powder for solution, containing excipients without active substance, will be injected locally into several sites across the glabellar region.

Primary outcome measure

  • For North America: Percentage of participants responding to treatment [ Time Frame: At week 4 ]
  • For EU and ROW: Percentage of participants responding to treatment as measured by ≥2-grades improvement on the ILA at maximum frown [ Time Frame: From baseline to week 4 ]

Central Contacts and Locations

Central contacts

Ipsen Recruitment Enquiries

see emailclinical.trials@ipsen.com

Locations

Clinical Testing of Beverly Hills

Recruiting

Los Angeles, California, United States, 91436

Eye Research Foundation

Recruiting

Newport Beach, California, United States, 92663

Steve Yoelin MD Medical Associates Inc

Recruiting

Newport Beach, California, United States, 92663

Skin and Beauty Center

Recruiting

Pasadena, California, United States, 91105

DMR Research, PLLC

Recruiting

Westport, Connecticut, United States, 06880

Skin and Cancer Associates (SCA) and the Center for Cosmetic Enhancement (CCE) - Aventura

Recruiting

Aventura, Florida, United States, 33180

Weinkle Dermatology

Recruiting

Bradenton, Florida, United States, 34209

Miami Dermatology & Laser Research

Recruiting

Miami, Florida, United States, 33133

Kavali Plastic Surgery and Skin Renewal Center

Recruiting

Atlanta, Georgia, United States, 30328

DeNova Research

Recruiting

Chicago, Illinois, United States, 60610

Chicago Cosmetic and Dermatologic Research

Recruiting

Chicago, Illinois, United States, 60654-5826

LASSI - Laser and Skin Surgery Center of Indiana

Recruiting

Indianapolis, Indiana, United States, 46260

DelRicht Research

Recruiting

New Orleans, Louisiana, United States, 70115

Etre, Cosmetic Dermatology and Laser Center

Recruiting

New Orleans, Louisiana, United States, 70130

Maryland Laser, Skin, & Vein Institute, LLC (MDLSV)

Recruiting

Hunt Valley, Maryland, United States, 21030

Lawrence J. Green, MD. LLC

Recruiting

Rockville, Maryland, United States, 20850

SkinCare Physicians

Recruiting

Chestnut Hill, Massachusetts, United States, 02467

Michigan Center for Research Company

Recruiting

Clarkston, Michigan, United States, 48346

Skin Specialists PC dba Schlessinger MD

Recruiting

Omaha, Nebraska, United States, 68144

StracSkin

Recruiting

Portsmouth, New Hampshire, United States, 03801

Rejuva Center at Williams

Recruiting

Latham, New York, United States, 12110

The Center for Dermatology, Cosmetic & Laser Surgery

Recruiting

Mount Kisco, New York, United States, 10549

Luxurgery

Recruiting

New York, New York, United States, 10021

Dr. Z. Paul Lorenc MD, Office Of

Recruiting

New York, New York, United States, 10028

Skin Search Of Rochester, Inc.

Recruiting

Rochester, New York, United States, 14623

Aesthetic Solutions P.A.

Recruiting

Chapel Hill, North Carolina, United States, 27517

Dermatology, Laser & Vein Specialists of the Carolinas (DLVSC) - Charlotte Office

Recruiting

Charlotte, North Carolina, United States, 28207

Nash Research Group, LLC

Recruiting

Powell, Ohio, United States, 43065

Oregon Dermatology and Research Center

Recruiting

Portland, Oregon, United States, 97210

Paddington Testing Company

Recruiting

Philadelphia, Pennsylvania, United States, 19103

Brian S. Biesman MD, PLLC

Recruiting

Nashville, Tennessee, United States, 37203

Tennessee Clinical Research Center

Recruiting

Nashville, Tennessee, United States, 37215

More Information

Sponsor

Ipsen

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Ipsen on 2026-09-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.