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A Study to Assess the Effectiveness and Safety of IPN10200 Over Time in Adults With Moderate to Severe Wrinkle-like Lines Between the Eyebrows
Sponsor: Ipsen
Summary
The purpose of this study is to assess the effectiveness and safety of a single dose of IPN10200 compared to placebo (double-blind phase) and how well and safely repeat doses of IPN10200 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 IPN10200 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 IPN10200 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 IPN10200 or placebo. In the open-label phase (rollover participants from double-blind), eligible participants may receive additional cycles of IPN10200. In the open-label phase (de novo participants), participants will receive IPN10200 in the first cycle and eligible participants may receive additional cycles of IPN10200. 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.
Official title: A Phase III, Multicentre, Double-blind, Randomised, Placebo-controlled and Open-label Study to Evaluate the Efficacy and Safety of a Single Dose of IPN10200 in the Improvement of Moderate to Severe Glabellar Lines in Adult Participants, and to Evaluate the Long-term Efficacy and Safety of Repeat Doses of IPN10200 in the Same Indication
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
1300
Start Date
2026-02-18
Completion Date
2028-10-01
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
IPN10200
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.
Locations (60)
Rivkin Westside Aesthetics
Los Angeles, California, United States
Clinical Testing of Beverly Hills
Los Angeles, California, United States
Eye Research Foundation
Newport Beach, California, United States
Steve Yoelin MD Medical Associates Inc
Newport Beach, California, United States
Skin and Beauty Center
Pasadena, California, United States
Dermatology Cosmetic Laser Medical Associates of La Jolla Inc.
San Diego, California, United States
Southern California Dermatology, Inc.
Santa Ana, California, United States
DMR Research, PLLC
Westport, Connecticut, United States
Center for Dermatology and Dermatologic Surgery
Washington D.C., District of Columbia, United States
Skin and Cancer Associates (SCA) and the Center for Cosmetic Enhancement (CCE) - Aventura
Aventura, Florida, United States
Weinkle Dermatology
Bradenton, Florida, United States
Skin Research Institute
Coral Gables, Florida, United States
Miami Dermatology & Laser Research
Miami, Florida, United States
Kavali Plastic Surgery and Skin Renewal Center
Atlanta, Georgia, United States
DeNova Research
Chicago, Illinois, United States
Chicago Cosmetic and Dermatologic Research
Chicago, Illinois, United States
Advanced Dermatology, A Forefront Dermatology Practice
Lincolnshire, Illinois, United States
LASSI - Laser and Skin Surgery Center of Indiana
Indianapolis, Indiana, United States
Coleman Center For Cosmetic Dermatologic Surgery
Metairie, Louisiana, United States
DelRicht Research
New Orleans, Louisiana, United States
Etre, Cosmetic Dermatology and Laser Center
New Orleans, Louisiana, United States
Maryland Laser, Skin, & Vein Institute, LLC (MDLSV)
Hunt Valley, Maryland, United States
Lawrence J. Green, MD. LLC
Rockville, Maryland, United States
SkinCare Physicians
Chestnut Hill, Massachusetts, United States
Michigan Center for Research Company
Clarkston, Michigan, United States
Skin Specialists PC dba Schlessinger MD
Omaha, Nebraska, United States
StracSkin
Portsmouth, New Hampshire, United States
Rejuva Center at Williams
Latham, New York, United States
The Center for Dermatology, Cosmetic & Laser Surgery
Mount Kisco, New York, United States
Luxurgery
New York, New York, United States
Dr. Z. Paul Lorenc MD, Office Of
New York, New York, United States
Skin Search Of Rochester, Inc.
Rochester, New York, United States
Rochester Dermatologic Surgery, P.C.
Victor, New York, United States
Aesthetic Solutions P.A.
Chapel Hill, North Carolina, United States
Dermatology, Laser & Vein Specialists of the Carolinas (DLVSC) - Charlotte Office
Charlotte, North Carolina, United States
Nash Research Group, LLC
Powell, Ohio, United States
Oregon Dermatology and Research Center
Portland, Oregon, United States
Paddington Testing Company
Philadelphia, Pennsylvania, United States
Brian S. Biesman MD, PLLC
Nashville, Tennessee, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
Center for Clinical Studies
Webster, Texas, United States
Sas Aimed
Lyon, France
Institut Cyrnos
Nice, France
Thinkin SAS
Paris, France
Rosenpark Research GmbH
Darmstadt, Germany
Privatpraxis Dr. Hilton & Partner
Düsseldorf, Germany
Universitaet Hamburg - Institut fuer Biochemie und Molekularbiologie
Hamburg, Germany
Derma Science GmbH
Hamburg, Germany
Noahklinik- Klinik fuer Plastische Chirurgie
Kassel, Germany
Dermatologische Gemeinschaftspraxis
Mahlow, Germany
Skin Concept - Private Dermatology Practice
München, Germany
Haut- und Lasercentrum Potsdam
Potsdam, Germany
Akihabara Skin Clinic
Chiyoda-ku, Japan
Medical Corporation Chiseikai - Tokyo Center Clinic
Chūōku, Japan
Josui Dermatology Clinic
Fukuoka, Japan
Clinica BellaForma
Minatoku, Japan
Forest Palace Dermatology Clinic
Nerima-ku, Japan
Kume Derma Clinic
Sakaishi, Japan
Kotoni Tower Dermatology and Plastic Surgery
Sapporo, Japan
Yoshikawa Skin Clinic
Takatsuki-shi, Japan