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RECRUITING
NCT07435428
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

IPN10200

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

BIOLOGICAL

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