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A Study to Assess the Effectiveness and Safety of IPN10200 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 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 IPN10200 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.
Official title: A Phase III, Multicentre, Double-blind, Randomised, Placebo-controlled, Parallel Group 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
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2026-02-27
Completion Date
2027-07-15
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 (23)
Skin Wellness Dermatology - Homewood
Birmingham, Alabama, United States
Advanced Research Associates
Glendale, Arizona, United States
Avacare
Scottsdale, Arizona, United States
Investigate MD, LLC
Scottsdale, Arizona, United States
Ablon Skin Institute and Research Center
Manhattan Beach, California, United States
Keith A. Marcus, MD Inc
Redondo Beach, California, United States
West Dermatology
San Diego, California, United States
Ava T. Shamban, M.D., Inc.
Santa Monica, California, United States
Art of Skin MD
Solana Beach, California, United States
Pacific Clinical Innovations Inc.
Vista, California, United States
Skin Research Institute
Coral Gables, Florida, United States
ICON Dermatology and Aesthetics
Bethesda, Maryland, United States
Clinical Research Center of the Carolinas
Charleston, South Carolina, United States
Westlake Dermatology & Cosmetic Surgery - Westlake
Austin, Texas, United States
Dermatology and Laser Surgery Center
Houston, Texas, United States
Pflugerville Dermatology Clinical Research Center, Inc. d/b/a Austin Institute for Clinical Research
Pflugerville, Texas, United States
SkinDC
Arlington, Virginia, United States
Carruthers and Humphrey Cosmetic Medicine
Vancouver, British Columbia, Canada
Pacific Dermaesthetics Inc.
Vancouver, British Columbia, Canada
Institute of Cosmetic and Laser Surgery
Oakville, Ontario, Canada
Sweat clinics of canada
Toronto, Ontario, Canada
Bertucci MedSpa
Woodbridge, Ontario, Canada
Centre de Recherche Dermatologique de Quebec
Québec, Quebec, Canada