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

NCT07427797 | Recruiting Phase 3 FDA Drug

• 1 other identifier: CLIN-10200-459
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 23

Brief Summary

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.

Conditions

Moderate to Severe Glabellar Lines

Outcome Measures

Primary Outcomes (2)

• For North America: Percentage of participants responding to treatment

  Measured by the multicomponent response of ≥2-grade improvement from baseline 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.

  From baseline to week 4

• For EU and ROW: Percentage of participants responding to treatment

  Measured by a ≥2-grade improvement on Investigator's Live Assessment (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 (32)

• For North America: Percentage of participants responding to treatment

  At week 24

• For EU and ROW: Response to treatment as measured by a score of 'None' or 'Mild' at Week 4 on the ILA at maximum frown

  At week 24

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

  At week 24

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

  At week 24

• 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

Study Arms (2)

Corabotase group

EXPERIMENTAL

Participants will receive Corabotase through injections into the selected muscles on Day 1.

Biological: Corabotase

Placebo group

PLACEBO COMPARATOR

Participants will receive placebo through injections into the selected muscles on Day 1.

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.

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 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.

Sponsors & Collaborators

• Ipsen: lead

Study Sites (23)

Skin Wellness Dermatology - Homewood

Birmingham, Alabama, 35209, United States

RECRUITING

Advanced Research Associates

Glendale, Arizona, 85308, United States

RECRUITING

Avacare

Scottsdale, Arizona, 85260, United States

NOT YET RECRUITING

Investigate MD, LLC

Scottsdale, Arizona, 85260, United States

RECRUITING

Ablon Skin Institute and Research Center

Manhattan Beach, California, 90266, United States

RECRUITING

Keith A. Marcus, MD Inc

Redondo Beach, California, 90277, United States

RECRUITING

West Dermatology

San Diego, California, 92121, United States

NOT YET RECRUITING

Ava T. Shamban, M.D., Inc.

Santa Monica, California, 90404, United States

RECRUITING

Art of Skin MD

Solana Beach, California, 92075, United States

RECRUITING

Pacific Clinical Innovations Inc.

Vista, California, 92083, United States

RECRUITING

Skin Research Institute

Coral Gables, Florida, 33146, United States

RECRUITING

ICON Dermatology and Aesthetics

Bethesda, Maryland, 20852, United States

RECRUITING

Clinical Research Center of the Carolinas

Charleston, South Carolina, 29407, United States

NOT YET RECRUITING

Westlake Dermatology & Cosmetic Surgery - Westlake

Austin, Texas, 78746-5059, United States

RECRUITING

Dermatology and Laser Surgery Center

Houston, Texas, 77004, United States

RECRUITING

Pflugerville Dermatology Clinical Research Center, Inc. d/b/a Austin Institute for Clinical Research

Pflugerville, Texas, 78660, United States

RECRUITING

SkinDC

Arlington, Virginia, 22209, United States

RECRUITING

Carruthers and Humphrey Cosmetic Medicine

Vancouver, British Columbia, V5Z 4E1, Canada

RECRUITING

Pacific Dermaesthetics Inc.

Vancouver, British Columbia, V6H4E1, Canada

NOT YET RECRUITING

Institute of Cosmetic and Laser Surgery

Oakville, Ontario, L6J 7W5, Canada

RECRUITING

Sweat clinics of canada

Toronto, Ontario, M5R 3N8, Canada

RECRUITING

Bertucci MedSpa

Woodbridge, Ontario, L4L 8E2, Canada

NOT YET RECRUITING

Centre de Recherche Dermatologique de Quebec

Québec, Quebec, G1V4X7, Canada

NOT YET RECRUITING

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

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 23, 2026
• Study Start: February 27, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): July 15, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07

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

CA (6); US (17)