IPN10200 for Frown Lines
(LAURITE 2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants 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, eligible participants may receive additional cycles of IPN10200.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants may receive repeat doses of IPN10200 to evaluate long-term efficacy and safety
What Are the Treatments Tested in This Trial?
Interventions
- IPN10200
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive IPN10200 via injection into the selected muscles on Day 1 of the double-blind (DB) phase. Participants who are new to treatment (the de novo phase) will receive IPN10200 via injections into the selected muscles during the first and subsequent treatment cycles.
Participants will receive placebo via injection into the selected muscles on Day 1 of the DB phase.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ipsen
Lead Sponsor
David Loew
Ipsen
Chief Executive Officer since 2020
BA in Business Administration and MBA from the University of St. Gallen, Switzerland
Sandra Silvestri
Ipsen
Chief Medical Officer since 2023
MD, PhD
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