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RECRUITING
NCT07427797
PHASE3

A Study to Assess the Effectiveness and Safety of IPN10200 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 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

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 (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