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300 Participants NeededMy employer runs this trial

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

(LAURITE 1 Trial)

Recruiting at 22 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Ipsen
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human 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 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 IPN10200 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.

Who Is on the Research Team?

IM

Ipsen Medical Director

Principal Investigator

Ipsen

Are You a Good Fit for This Trial?

Inclusion Criteria

* Is not a sponsor employee or clinical research unit personnel directly affiliated with the study or is not an immediate family member. Immediate family is defined as a spouse, parent, child or sibling whether biological or legally adopted.
* Dissatisfied or very dissatisfied (Grade 2 or 3) with their lines at baseline, as assessed by the SLS.
* For female participants: Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
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What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: IPN10200 groupExperimental Treatment1 Intervention
Group II: Placebo groupPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ipsen

Lead Sponsor

Trials
358
Recruited
74,600+
David Loew profile image

David Loew

Ipsen

Chief Executive Officer since 2020

BA in Business Administration and MBA from the University of St. Gallen, Switzerland

Sandra Silvestri profile image

Sandra Silvestri

Ipsen

Chief Medical Officer since 2023

MD, PhD

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