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NCT07435428PHASE3Recruiting

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

Ipsen

Start Date

2/18/2026

Completion Date

10/1/2028

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.

Eligibility Criteria

Age Range: 18 years to 80 years

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.

Interventions

BIOLOGICAL

Corabotase

BIOLOGICAL

Placebo

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Conditions

Moderate to Severe Glabellar Lines

Locations

Rivkin Westside Aesthetics

Los Angeles, California 90025

United States

Clinical Testing of Beverly Hills

Los Angeles, California 91436

United States

Eye Research Foundation

Newport Beach, California 92663

United States

Steve Yoelin MD Medical Associates Inc

Newport Beach, California 92663

United States

Skin and Beauty Center

Pasadena, California 91105

United States

Dermatology Cosmetic Laser Medical Associates of La Jolla Inc.

San Diego, California 92121

United States

Southern California Dermatology, Inc.

Santa Ana, California 92701

United States

DMR Research, PLLC

Westport, Connecticut 06880

United States

Center for Dermatology and Dermatologic Surgery

Washington D.C., District of Columbia 20037

United States

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

Aventura, Florida 33180

United States

Weinkle Dermatology

Bradenton, Florida 34209

United States

Skin Research Institute

Coral Gables, Florida 33146

United States

Miami Dermatology & Laser Research

Miami, Florida 33133

United States

Kavali Plastic Surgery and Skin Renewal Center

Atlanta, Georgia 30328

United States

DeNova Research

Chicago, Illinois 60610

United States

Chicago Cosmetic and Dermatologic Research

Chicago, Illinois 60654-5826

United States

Advanced Dermatology, A Forefront Dermatology Practice

Lincolnshire, Illinois 60069

United States

LASSI - Laser and Skin Surgery Center of Indiana

Indianapolis, Indiana 46260

United States

Coleman Center For Cosmetic Dermatologic Surgery

Metairie, Louisiana 70006

United States

DelRicht Research

New Orleans, Louisiana 70115

United States

Etre, Cosmetic Dermatology and Laser Center

New Orleans, Louisiana 70130

United States

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

Hunt Valley, Maryland 21030

United States

Lawrence J. Green, MD. LLC

Rockville, Maryland 20850

United States

SkinCare Physicians

Chestnut Hill, Massachusetts 02467

United States

Michigan Center for Research Company

Clarkston, Michigan 48346

United States

Skin Specialists PC dba Schlessinger MD

Omaha, Nebraska 68144

United States

StracSkin

Portsmouth, New Hampshire 03801

United States

Rejuva Center at Williams

Latham, New York 12110

United States

The Center for Dermatology, Cosmetic & Laser Surgery

Mount Kisco, New York 10549

United States

Luxurgery

New York, New York 10021

United States

Dr. Z. Paul Lorenc MD, Office Of

New York, New York 10028

United States

Skin Search Of Rochester, Inc.

Rochester, New York 14623

United States

Rochester Dermatologic Surgery, P.C.

Victor, New York 14561

United States

Aesthetic Solutions P.A.

Chapel Hill, North Carolina 27517

United States

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

Charlotte, North Carolina 28207

United States

Nash Research Group, LLC

Powell, Ohio 43065

United States

Oregon Dermatology and Research Center

Portland, Oregon 97210

United States

Paddington Testing Company

Philadelphia, Pennsylvania 19103

United States

Brian S. Biesman MD, PLLC

Nashville, Tennessee 37203

United States

Tennessee Clinical Research Center

Nashville, Tennessee 37215

United States

Center for Clinical Studies

Webster, Texas 77598

United States

Sas Aimed

Lyon, 69006

France

Institut Cyrnos

Nice, 6000

France

Thinkin SAS

Paris, 75016

France

Rosenpark Research GmbH

Darmstadt, 64283

Germany

Privatpraxis Dr. Hilton & Partner

Düsseldorf, 40212

Germany

Universitaet Hamburg - Institut fuer Biochemie und Molekularbiologie

Hamburg, 20146

Germany

Derma Science GmbH

Hamburg, 22609

Germany

Noahklinik- Klinik fuer Plastische Chirurgie

Kassel, 34117

Germany

Dermatologische Gemeinschaftspraxis

Mahlow, 15831

Germany

Skin Concept - Private Dermatology Practice

München, 80333

Germany

Haut- und Lasercentrum Potsdam

Potsdam, 14467

Germany

Akihabara Skin Clinic

Chiyoda-ku, 101-0021

Japan

Medical Corporation Chiseikai - Tokyo Center Clinic

Chūōku, 103-0027

Japan

Josui Dermatology Clinic

Fukuoka, 810-0022

Japan

Clinica BellaForma

Minatoku, 107-0052

Japan

Forest Palace Dermatology Clinic

Nerima-ku, 177-0041

Japan

Kume Derma Clinic

Sakaishi, 593-8324

Japan

Kotoni Tower Dermatology and Plastic Surgery

Sapporo, 063-0812

Japan

Yoshikawa Skin Clinic

Takatsuki-shi, 569-0824

Japan