RecruitingPhase 3NCT07779252

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

A Phase III, Multicentre, Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of IPN10200 in the Improvement of the Appearance of Moderate To Severe Glabellar Lines in Adult Chinese Participants


Sponsor

Ipsen

Enrollment

160 participants

Start Date

Aug 25, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to find out about the effectiveness and safety of a single dose of corabotase (also known as IPN10200) compared to placebo works in 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. In this study, all participants will receive a single injection of either corabotase (the study drug) or placebo. 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 corabotase 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, and clinical evaluations. 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Corabotase and a biological treatment called Placebo for people with moderate to severe glabellar lines. The study is currently recruiting participants at 9 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCorabotase

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

BIOLOGICALPlacebo

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(9)

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Xiangya School of Medicine at Central South University

Changsha, Hunan, China

Drum Tower Hospital, Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Wuxi People's Hospital

Wuxi, Jiangsu, China

Huashan Hospital Affiliated to Fudan University

Jing’an, Shanghai Muncipality, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Peking university first hospital

Beijing, China

Peking Union Medical College Hospital (PUMCH)

Beijing, China

View Full Details on ClinicalTrials.gov

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NCT07779252


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