IPN10200 for Frown Lines

(LAURITE 1 Trial)

Not currently recruiting at 22 trial locations
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?

This trial tests a new treatment called IPN10200, an experimental injection, to determine if it can safely and effectively reduce moderate to severe frown lines, the wrinkles between the eyebrows. Participants will receive either one injection of IPN10200 or a placebo, a substance with no active drug, and will be monitored over a year. The trial is open to adults dissatisfied with their frown lines who have had them for some time, but it excludes those with recent facial surgeries or certain medical conditions. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to the development of a new treatment.

Do I need to stop my current medications for the trial?

The trial requires that you stop using certain medications that affect neuromuscular transmission, aminoglycoside antibiotics, and systemic retinoids at least 30 days before starting. Other medications may need to be stopped if they interfere with the study, as determined by the investigator.

Is there any evidence suggesting that IPN10200 is likely to be safe for humans?

Research shows that IPN10200, a treatment tested for reducing frown lines between the eyebrows, is generally well-tolerated. In earlier studies, participants using IPN10200 did not report major safety issues. The treatment has a good safety record, as it did not cause significant side effects, suggesting it is generally safe for use. Additionally, IPN10200 has been found to reduce wrinkles for a longer duration compared to treatments like Dysport. Overall, the evidence indicates that IPN10200 is safe, with participants experiencing only minor side effects.12345

Why do researchers think this study treatment might be promising for frown lines?

Researchers are excited about IPN10200 for treating frown lines because, unlike traditional options like botulinum toxin injections, IPN10200 may offer a novel mechanism or formulation that could enhance its effectiveness or duration. While most current treatments temporarily paralyze facial muscles to reduce lines, IPN10200 might provide longer-lasting results or reduce the need for frequent re-treatments. This new approach has the potential to improve patient satisfaction by offering a more convenient and potentially more effective solution for managing frown lines.

What evidence suggests that IPN10200 might be an effective treatment for frown lines?

Research shows that IPN10200, which participants in this trial may receive, significantly improves the appearance of frown lines—those lines between the eyebrows that deepen with age or facial expressions—compared to a placebo. Studies have found that IPN10200 not only outperforms a placebo but also lasts longer than Dysport, another treatment for these lines. Previous research suggests that IPN10200 is well-tolerated, causing no major side effects. These findings make IPN10200 a promising option for reducing frown lines.12345

Who Is on the Research Team?

IM

Ipsen Medical Director

Principal Investigator

Ipsen

Are You a Good Fit for This Trial?

This trial is for adults (18+) with moderate to severe frown lines between the eyebrows who are unhappy with their appearance. Participants must be able to follow study instructions and not have had recent cosmetic procedures, certain skin conditions, or specific medical issues that could interfere with the study.

Inclusion Criteria

For female participants: Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
I have moderate or severe GL at MF, confirmed by a doctor using a photo scale.
I have moderate or severe GL at MF, based on my doctor's assessment.
See 6 more

Exclusion Criteria

I have not had any Botox or similar injections in the past 9 months.
Presence of any scars, piercings or tattoos (including micro blading of the eyebrows) in or around the treatment area that have occurred within 6 months prior to baseline, or which in the investigator's opinion, could interfere with evaluations
I have an active infection or skin problem on my upper face.
See 22 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 20 days
At least 1 visit to the study centre

Treatment

Participants receive a single injection of IPN10200 or placebo

Day 1
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks
Regular visits to the study centre and 1 telephone call visit

What Are the Treatments Tested in This Trial?

Interventions

  • IPN10200

Trial Overview

The study compares a single injection of IPN10200 (a new treatment) versus a placebo to see if it improves moderate to severe frown lines. Participants are randomly assigned and monitored over about one year through clinic visits and health checks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Corabotase 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

Citations

A Study to Assess the Safety and Efficacy of IPN10200 in ...

The purpose of this study is to assess the safety and efficacy profile of increasing doses of IPN10200 in comparison to placebo.

Ipsen's IPN10200 Demonstrates Long-Lasting Efficacy in ...

IPN10200 demonstrated significant improvement in glabellar lines versus placebo, with a longer effect duration than Dysport, and no safety ...

Ipsen's LANTIC Phase II in aesthetics delivers a first-in- ...

IPN10200 was shown to be well-tolerated with no safety concerns reported with any of the evaluated doses of IPN10200 across Stage 1. Data will ...

IPN10200 for Frown Lines (LAURITE 2 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) ...

NCT07427797 | A Study to Assess the Effectiveness and ...

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 ...