NCT07435428

A Study to Assess the Effectiveness and Safety of IPN10200 Over Time in Adults With Moderate to Severe Wrinkle-like Lines Between the Eyebrows

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,300 (estimated)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Moderate to Severe Glabellar Lines

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-18
• Primary completion: 2026-12-15
• Completion: 2028-10-01
• First posted: 2026-02-27
• Last updated: 2026-04-02

Locations

60 sites across 4 countries: United States, France, Germany, Japan

Regulatory

• FDA-regulated drug study