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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

Study acronym: LAURITE 1
StatusActive, Not Recruiting
PhasePhase 3
SponsorIpsen
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Re-verified, no change to tracked fieldsv7
  2. Minor Enrollment closed, study ongoing Enrollment target: estimated 300 to confirmed 309 · Site details revised at 23 of 23 sitesv6 Show 2 more changesShow less
    • Enrollment target: estimated 300 to confirmed 309
    • Site details revised at 23 of 23 sites
  3. Minor Interventions: IPN10200 (Biological), Placebo (Biological) to Corabotase (Biological), Placebo (Biological)v5
  4. Minor Site details revised at 8 of 23 sitesv4
  5. Minor Site details revised at 7 of 23 sitesv3
  6. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 23 · Completion date: Nov 1, 2027 to Jul 15, 2027 · Start date changed from estimate of Feb 25, 2026 to Feb 27, 2026v2 Show 3 more changesShow less
    • Study sites: 0 to 23
    • Completion date: Nov 1, 2027 to Jul 15, 2027
    • Start date changed from estimate of Feb 25, 2026 to Feb 27, 2026
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
46 trials monitored
See 4 trials at risk
The purpose of this study is to assess the effectiveness and safety of Corabotase (also known as 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 Corabotase 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.
Trial Details
NCT Number NCT07427797
Lead Sponsor Ipsen
Conditions Moderate to Severe Glabellar Lines
Enrollment 309 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov