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A Study to Assess the Effectiveness and Safety of IPN10200 in Adult Chinese Participants With Moderate to Severe Wrinkle-like Lines Between the Eyebrows
Sponsor: Ipsen
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2026-08-25
Completion Date
2028-04-10
Last Updated
2026-09-14
Healthy Volunteers
No
Conditions
Interventions
Corabotase
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 (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