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

NCT07435428 | Recruiting Phase 3 FDA Drug

• 2 other identifiers: CLIN-10200-4582025-522618-22-00
• Study Type: interventional
• Target: 1,300
• Locations: 4 countries
• Sites: 60

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

Outcome Measures

Primary Outcomes (2)

• For North America: Percentage of participants responding to treatment

  Measured by the multi-component response of ≥2-grade improvement and a score of 'None' or 'Mild' on Investigator's Live Assessment (ILA) and Subject's Self-Assessment (SSA) at maximum frown. ILA: a validated 4-point photographic scale used to assess the severity and appearance of glabellar lines at maximum frown, where grade 0 = "None," grade 1 = "Mild," grade 2 = "Moderate," and grade 3 = "Severe." SSA: a 4-point categorical scale used to assess the appearance of glabellar lines at maximum frown, where grade 0 = "No wrinkles," grade 1 = "Mild wrinkles," grade 2 = "Moderate wrinkles," and grade 3 = "Severe wrinkles."

  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

  ILA: a validated 4-point photographic scale used to assess the severity and appearance of glabellar lines at maximum frown, where grade 0 = "None," grade 1 = "Mild," grade 2 = "Moderate," and grade 3 = "Severe."

  From baseline to week 4

Secondary Outcomes (26)

• For Double Blind (DB) phase: For North America: Percentage of participants responding to treatment

  At week 24

• For DB phase: Percentage participants responding to treatment as measured by a score of "None" or "Mild on ILA at maximum frown

  At each post-treatment visit except week 4 (For EU and ROW) and week 24 (for United States) up to week 24

• For DB phase: Percentage of participants responding to treatment as measured by a score of "None" or "Mild on SSA at maximum frown

  At week 24

• For DB phase: For all regions except United States: Percentage of participants satisfied with their facial appearance after the treatment as measured by a score of 'Very Satisfied' or 'Satisfied' on Subject's Level of Satisfaction (SLS)

  At week 4 and week 24

• For DB and Open Label (OL) phase: Percentage of participants responding to treatment as measured by a score of "None" or "Mild" on ILA at maximum frown

  DB phase: From baseline to each post-treatment visit until week 52 (except week 4 (for EU and all other regions) and week 24); OL phase: From baseline to each post-treatment visit until week 104

Study Arms (2)

Corabotase group

EXPERIMENTAL

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.

Biological: Corabotase

Placebo group

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

Placebo BIOLOGICAL

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

Placebo group

Corabotase BIOLOGICAL

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

Also known as: IPN10200

Corabotase group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Ipsen: lead

Study Sites (60)

Rivkin Westside Aesthetics

Los Angeles, California, 90025, United States

NOT YET RECRUITING

Clinical Testing of Beverly Hills

Los Angeles, California, 91436, United States

RECRUITING

Eye Research Foundation

Newport Beach, California, 92663, United States

RECRUITING

Steve Yoelin MD Medical Associates Inc

Newport Beach, California, 92663, United States

RECRUITING

Skin and Beauty Center

Pasadena, California, 91105, United States

RECRUITING

Dermatology Cosmetic Laser Medical Associates of La Jolla Inc.

San Diego, California, 92121, United States

NOT YET RECRUITING

Southern California Dermatology, Inc.

Santa Ana, California, 92701, United States

NOT YET RECRUITING

DMR Research, PLLC

Westport, Connecticut, 06880, United States

RECRUITING

Center for Dermatology and Dermatologic Surgery

Washington D.C., District of Columbia, 20037, United States

NOT YET RECRUITING

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

Aventura, Florida, 33180, United States

RECRUITING

Weinkle Dermatology

Bradenton, Florida, 34209, United States

RECRUITING

Skin Research Institute

Coral Gables, Florida, 33146, United States

NOT YET RECRUITING

Miami Dermatology & Laser Research

Miami, Florida, 33133, United States

RECRUITING

Kavali Plastic Surgery and Skin Renewal Center

Atlanta, Georgia, 30328, United States

RECRUITING

DeNova Research

Chicago, Illinois, 60610, United States

RECRUITING

Chicago Cosmetic and Dermatologic Research

Chicago, Illinois, 60654-5826, United States

RECRUITING

Advanced Dermatology, A Forefront Dermatology Practice

Lincolnshire, Illinois, 60069, United States

NOT YET RECRUITING

LASSI - Laser and Skin Surgery Center of Indiana

Indianapolis, Indiana, 46260, United States

RECRUITING

Coleman Center For Cosmetic Dermatologic Surgery

Metairie, Louisiana, 70006, United States

NOT YET RECRUITING

DelRicht Research

New Orleans, Louisiana, 70115, United States

RECRUITING

Etre, Cosmetic Dermatology and Laser Center

New Orleans, Louisiana, 70130, United States

RECRUITING

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

Hunt Valley, Maryland, 21030, United States

RECRUITING

Lawrence J. Green, MD. LLC

Rockville, Maryland, 20850, United States

RECRUITING

SkinCare Physicians

Chestnut Hill, Massachusetts, 02467, United States

RECRUITING

Michigan Center for Research Company

Clarkston, Michigan, 48346, United States

RECRUITING

Skin Specialists PC dba Schlessinger MD

Omaha, Nebraska, 68144, United States

RECRUITING

StracSkin

Portsmouth, New Hampshire, 03801, United States

RECRUITING

Rejuva Center at Williams

Latham, New York, 12110, United States

RECRUITING

The Center for Dermatology, Cosmetic & Laser Surgery

Mount Kisco, New York, 10549, United States

RECRUITING

Luxurgery

New York, New York, 10021, United States

RECRUITING

Dr. Z. Paul Lorenc MD, Office Of

New York, New York, 10028, United States

RECRUITING

Skin Search Of Rochester, Inc.

Rochester, New York, 14623, United States

RECRUITING

Rochester Dermatologic Surgery, P.C.

Victor, New York, 14561, United States

NOT YET RECRUITING

Aesthetic Solutions P.A.

Chapel Hill, North Carolina, 27517, United States

RECRUITING

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

Charlotte, North Carolina, 28207, United States

RECRUITING

Nash Research Group, LLC

Powell, Ohio, 43065, United States

RECRUITING

Oregon Dermatology and Research Center

Portland, Oregon, 97210, United States

RECRUITING

Paddington Testing Company

Philadelphia, Pennsylvania, 19103, United States

RECRUITING

Brian S. Biesman MD, PLLC

Nashville, Tennessee, 37203, United States

RECRUITING

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

RECRUITING

Center for Clinical Studies

Webster, Texas, 77598, United States

NOT YET RECRUITING

Sas Aimed

Lyon, 69006, France

NOT YET RECRUITING

Institut Cyrnos

Nice, 6000, France

NOT YET RECRUITING

Thinkin SAS

Paris, 75016, France

NOT YET RECRUITING

Rosenpark Research GmbH

Darmstadt, 64283, Germany

NOT YET RECRUITING

Privatpraxis Dr. Hilton & Partner

Düsseldorf, 40212, Germany

NOT YET RECRUITING

Universitaet Hamburg - Institut fuer Biochemie und Molekularbiologie

Hamburg, 20146, Germany

NOT YET RECRUITING

Derma Science GmbH

Hamburg, 22609, Germany

NOT YET RECRUITING

Noahklinik- Klinik fuer Plastische Chirurgie

Kassel, 34117, Germany

NOT YET RECRUITING

Dermatologische Gemeinschaftspraxis

Mahlow, 15831, Germany

NOT YET RECRUITING

Skin Concept - Private Dermatology Practice

München, 80333, Germany

NOT YET RECRUITING

Haut- und Lasercentrum Potsdam

Potsdam, 14467, Germany

NOT YET RECRUITING

Akihabara Skin Clinic

Chiyoda-ku, 101-0021, Japan

RECRUITING

Medical Corporation Chiseikai - Tokyo Center Clinic

Chūōku, 103-0027, Japan

RECRUITING

Josui Dermatology Clinic

Fukuoka, 810-0022, Japan

RECRUITING

Clinica BellaForma

Minatoku, 107-0052, Japan

RECRUITING

Forest Palace Dermatology Clinic

Nerima-ku, 177-0041, Japan

RECRUITING

Kume Derma Clinic

Sakaishi, 593-8324, Japan

RECRUITING

Kotoni Tower Dermatology and Plastic Surgery

Sapporo, 063-0812, Japan

RECRUITING

Yoshikawa Skin Clinic

Takatsuki-shi, 569-0824, Japan

RECRUITING

Central Study Contacts

Ipsen Recruitment Enquiries

CONTACT

see email; clinical.trials@ipsen.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 27, 2026
• Study Start: February 18, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): October 1, 2028
• Last Updated: July 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and/or EU.
• Access Criteria: Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).

Locations

DE (8); US (41); FR (3); JP (8)